Trial Outcomes & Findings for Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy (NCT NCT00980954)
NCT ID: NCT00980954
Last Updated: 2025-12-31
Results Overview
Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
236 participants
Primary outcome timeframe
From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported.
Results posted on
2025-12-31
Participant Flow
Participant milestones
| Measure |
Arm I: Cisplatin/Radiation Therapy
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
118
|
|
Overall Study
Eligible
|
109
|
103
|
|
Overall Study
COMPLETED
|
109
|
103
|
|
Overall Study
NOT COMPLETED
|
9
|
15
|
Reasons for withdrawal
| Measure |
Arm I: Cisplatin/Radiation Therapy
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
9
|
15
|
Baseline Characteristics
Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
Baseline characteristics by cohort
| Measure |
Arm I: Cisplatin/Radiation Therapy
n=109 Participants
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
n=103 Participants
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
47 years
n=1000 Participants
|
45 years
n=1986 Participants
|
46 years
n=2008 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=1000 Participants
|
103 Participants
n=1986 Participants
|
212 Participants
n=2008 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=1000 Participants
|
10 Participants
n=1986 Participants
|
23 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=1000 Participants
|
92 Participants
n=1986 Participants
|
187 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
2 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
2 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Asian
|
42 Participants
n=1000 Participants
|
40 Participants
n=1986 Participants
|
82 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=1000 Participants
|
9 Participants
n=1986 Participants
|
13 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=1000 Participants
|
49 Participants
n=1986 Participants
|
109 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1000 Participants
|
4 Participants
n=1986 Participants
|
5 Participants
n=2008 Participants
|
|
Zubrod performance status
0
|
87 Participants
n=1000 Participants
|
79 Participants
n=1986 Participants
|
166 Participants
n=2008 Participants
|
|
Zubrod performance status
1
|
22 Participants
n=1000 Participants
|
24 Participants
n=1986 Participants
|
46 Participants
n=2008 Participants
|
|
Hysterectomy Procedure
Open
|
64 Participants
n=1000 Participants
|
54 Participants
n=1986 Participants
|
118 Participants
n=2008 Participants
|
|
Hysterectomy Procedure
Laparoscopic
|
26 Participants
n=1000 Participants
|
22 Participants
n=1986 Participants
|
48 Participants
n=2008 Participants
|
|
Hysterectomy Procedure
Robotic
|
19 Participants
n=1000 Participants
|
27 Participants
n=1986 Participants
|
46 Participants
n=2008 Participants
|
|
Histologic Type
Squamous cell carcinoma
|
88 Participants
n=1000 Participants
|
74 Participants
n=1986 Participants
|
162 Participants
n=2008 Participants
|
|
Histologic Type
Adenosquamous carcinoma
|
6 Participants
n=1000 Participants
|
5 Participants
n=1986 Participants
|
11 Participants
n=2008 Participants
|
|
Histologic Type
Adenocarcinoma, not otherwise specificed (NOS)
|
15 Participants
n=1000 Participants
|
24 Participants
n=1986 Participants
|
39 Participants
n=2008 Participants
|
|
Histologic grade
Gx-Grade cannot be assessed
|
14 Participants
n=1000 Participants
|
15 Participants
n=1986 Participants
|
29 Participants
n=2008 Participants
|
|
Histologic grade
G1-Well differentiated
|
10 Participants
n=1000 Participants
|
5 Participants
n=1986 Participants
|
15 Participants
n=2008 Participants
|
|
Histologic grade
G2-Moderately differentiated
|
58 Participants
n=1000 Participants
|
52 Participants
n=1986 Participants
|
110 Participants
n=2008 Participants
|
|
Histologic grade
G3-Poorly differentiated
|
27 Participants
n=1000 Participants
|
31 Participants
n=1986 Participants
|
58 Participants
n=2008 Participants
|
|
FIGO Staging (clinical) [AJCC 6th Edition]
IA2
|
3 Participants
n=1000 Participants
|
6 Participants
n=1986 Participants
|
9 Participants
n=2008 Participants
|
|
FIGO Staging (clinical) [AJCC 6th Edition]
IB
|
97 Participants
n=1000 Participants
|
88 Participants
n=1986 Participants
|
185 Participants
n=2008 Participants
|
|
FIGO Staging (clinical) [AJCC 6th Edition]
IIA
|
9 Participants
n=1000 Participants
|
9 Participants
n=1986 Participants
|
18 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T0
|
2 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
3 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T1
|
1 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
3 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T1a1
|
1 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
2 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T1a2
|
2 Participants
n=1000 Participants
|
6 Participants
n=1986 Participants
|
8 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T1b
|
4 Participants
n=1000 Participants
|
8 Participants
n=1986 Participants
|
12 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T1b1
|
39 Participants
n=1000 Participants
|
34 Participants
n=1986 Participants
|
73 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T1b2
|
23 Participants
n=1000 Participants
|
15 Participants
n=1986 Participants
|
38 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T2
|
6 Participants
n=1000 Participants
|
10 Participants
n=1986 Participants
|
16 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T2b
|
30 Participants
n=1000 Participants
|
24 Participants
n=1986 Participants
|
54 Participants
n=2008 Participants
|
|
Pathologic T-Stage
T3b
|
1 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
3 Participants
n=2008 Participants
|
|
Pathologic N-Stage
N0
|
30 Participants
n=1000 Participants
|
26 Participants
n=1986 Participants
|
56 Participants
n=2008 Participants
|
|
Pathologic N-Stage
N1
|
79 Participants
n=1000 Participants
|
77 Participants
n=1986 Participants
|
156 Participants
n=2008 Participants
|
|
Pathologic M-Stage
M0
|
108 Participants
n=1000 Participants
|
103 Participants
n=1986 Participants
|
211 Participants
n=2008 Participants
|
|
Pathologic M-Stage
M1
|
1 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
|
Positive Parametrium
No
|
53 Participants
n=1000 Participants
|
58 Participants
n=1986 Participants
|
111 Participants
n=2008 Participants
|
|
Positive Parametrium
Yes
|
56 Participants
n=1000 Participants
|
45 Participants
n=1986 Participants
|
101 Participants
n=2008 Participants
|
|
Positive Pelvic Nodes
No
|
33 Participants
n=1000 Participants
|
23 Participants
n=1986 Participants
|
56 Participants
n=2008 Participants
|
|
Positive Pelvic Nodes
Yes
|
76 Participants
n=1000 Participants
|
80 Participants
n=1986 Participants
|
156 Participants
n=2008 Participants
|
|
Positive Para-Aortic Nodes
No
|
54 Participants
n=1000 Participants
|
43 Participants
n=1986 Participants
|
97 Participants
n=2008 Participants
|
|
Positive Para-Aortic Nodes
Yes
|
3 Participants
n=1000 Participants
|
5 Participants
n=1986 Participants
|
8 Participants
n=2008 Participants
|
|
Positive Para-Aortic Nodes
Not sampled / dissected
|
52 Participants
n=1000 Participants
|
55 Participants
n=1986 Participants
|
107 Participants
n=2008 Participants
|
|
Intention to use brachytherapy
No
|
61 Participants
n=1000 Participants
|
58 Participants
n=1986 Participants
|
119 Participants
n=2008 Participants
|
|
Intention to use brachytherapy
Yes
|
48 Participants
n=1000 Participants
|
45 Participants
n=1986 Participants
|
93 Participants
n=2008 Participants
|
|
Intended RT Modality
Standard RT
|
46 Participants
n=1000 Participants
|
41 Participants
n=1986 Participants
|
87 Participants
n=2008 Participants
|
|
Intended RT Modality
IMRT
|
63 Participants
n=1000 Participants
|
62 Participants
n=1986 Participants
|
125 Participants
n=2008 Participants
|
|
Intended RT Dose
45 Gy
|
35 Participants
n=1000 Participants
|
30 Participants
n=1986 Participants
|
65 Participants
n=2008 Participants
|
|
Intended RT Dose
50.4 Gy
|
74 Participants
n=1000 Participants
|
73 Participants
n=1986 Participants
|
147 Participants
n=2008 Participants
|
PRIMARY outcome
Timeframe: From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported.Population: Eligible participants
Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.
Outcome measures
| Measure |
Arm I: Cisplatin/Radiation Therapy
n=109 Participants
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
n=103 Participants
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Disease-free Survival (Percentage of Participants Alive Without Disease)
2 years
|
86.4 percentage of participants
Interval 80.8 to 92.0
|
82.1 percentage of participants
Interval 75.6 to 88.6
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease)
4 years
|
76.2 percentage of participants
Interval 69.1 to 83.4
|
76.9 percentage of participants
Interval 69.6 to 84.3
|
SECONDARY outcome
Timeframe: From randomization to death or last follow-up. Maximum follow-up time at time of analysis was 12.8 years. The 2- and 4-year survival estimates are reported.Population: Eligible participants
Overall survival is estimated by the Kaplan-Meier method. The distribution of survival estimates between the two arms is compared using the log rank test. Survival time is measured from the date of randomization to the date of death from any cause or last known follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.
Outcome measures
| Measure |
Arm I: Cisplatin/Radiation Therapy
n=109 Participants
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
n=103 Participants
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (Percentage of Participants Alive)
2 years
|
91.9 percentage of participants
Interval 87.4 to 96.4
|
91.4 percentage of participants
Interval 86.6 to 96.2
|
|
Overall Survival (Percentage of Participants Alive)
4 years
|
87.3 percentage of participants
Interval 81.6 to 93.0
|
89.0 percentage of participants
Interval 83.5 to 94.4
|
SECONDARY outcome
Timeframe: Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks)The FACT-GOG/NTX4 measures patient-reported symptoms of chemotherapy-induced peripheral neuropathy in cancer patients. Possible scores range from 0 to 16 with higher scores indicating a better condition. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks)The diarrhea-specific subscore of the FACIT-D measures patient-reported diarrhea symptoms. Possible scores range from 0 to 44 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks)The cervical cancer subscore of the FACT-Cx measures patient-reported symptoms and problems related to cervical cancer. Possible scores range from 0 to 60 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.Population: Eligible participants who started protocol treatment and were assessed for adverse events.
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
Arm I: Cisplatin/Radiation Therapy
n=107 Participants
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
n=101 Participants
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 1
|
13 Participants
|
4 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 2
|
43 Participants
|
30 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 3
|
39 Participants
|
44 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 4
|
8 Participants
|
21 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization to last follow-upPopulation: The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified objective, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up.Population: The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified objective, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to last follow-up.Population: The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified objective, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported.Population: Eligible participants stratified by ethnicity
NIH-required analysis. Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.
Outcome measures
| Measure |
Arm I: Cisplatin/Radiation Therapy
n=109 Participants
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
n=103 Participants
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity
Hispanic or Latino: 2 years
|
83.9 percentage of participants
Interval 66.7 to 100.0
|
77.8 percentage of participants
Interval 55.0 to 100.0
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity
Hispanic or Latino: 4 years
|
83.9 percentage of participants
Interval 66.7 to 100.0
|
64.8 percentage of participants
Interval 37.6 to 92.0
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity
Not Hispanic or Latino: 2 years
|
86.7 percentage of participants
Interval 80.9 to 92.6
|
83.4 percentage of participants
Interval 76.7 to 90.1
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity
Not Hispanic or Latino: 4 years
|
75.4 percentage of participants
Interval 67.7 to 83.1
|
79.0 percentage of participants
Interval 71.5 to 86.5
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity
Unknown or Not Reported: 2 years
|
NA percentage of participants
Cannot be calculated because the participant was censored prior to the timepoint.
|
0 percentage of participants
Interval 0.0 to 100.0
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity
Unknown or Not Reported: 4 years
|
NA percentage of participants
Cannot be calculated because the participant was censored prior to the timepoint.
|
0 percentage of participants
Interval 0.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported.Population: Eligible participants stratified by race
NIH-required analysis. Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.
Outcome measures
| Measure |
Arm I: Cisplatin/Radiation Therapy
n=109 Participants
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
n=103 Participants
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
Unknown or Not Reported: 2 years
|
0 percentage of participants
Interval 0.0 to 100.0
|
50 percentage of participants
Interval 8.9 to 91.1
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
American Indian or Alaska Native: 2 years
|
100 percentage of participants
SAS software does not compute a confidence interval when the estimate is 100%.
|
100 percentage of participants
SAS software does not compute a confidence interval when the estimate is 100%.
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
American Indian or Alaska Native: 4 years
|
NA percentage of participants
Cannot be calculated because the participant was censored prior to the timepoint.
|
NA percentage of participants
Cannot be calculated because the participant was censored prior to the timepoint.
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
Asian: 2 years
|
87.1 percentage of participants
Interval 78.2 to 96.0
|
74.4 percentage of participants
Interval 62.3 to 86.6
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
Asian: 4 years
|
76.0 percentage of participants
Interval 64.5 to 87.5
|
64.2 percentage of participants
Interval 50.3 to 78.0
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
Black or African American: 2 years
|
100 percentage of participants
SAS software does not compute a confidence interval when the estimate is 100%.
|
87.5 percentage of participants
Interval 68.3 to 100.0
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
Black or African American: 4 years
|
100 percentage of participants
SAS software does not compute a confidence interval when the estimate is 100%.
|
87.5 percentage of participants
Interval 68.3 to 100.0
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
White: 2 years
|
85.9 percentage of participants
Interval 78.3 to 93.5
|
89.3 percentage of participants
Interval 81.8 to 96.7
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
White: 4 years
|
75.4 percentage of participants
Interval 65.5 to 85.3
|
86.6 percentage of participants
Interval 78.1 to 95.0
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
More than one race: 2 years
|
100 percentage of participants
SAS software does not compute a confidence interval when the estimate is 100%
|
—
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
More than one race: 4 years
|
NA percentage of participants
Cannot be calculated because the participant was censored prior to the timepoint.
|
—
|
|
Disease-free Survival (Percentage of Participants Alive Without Disease) by Race
Unknown or Not Reported: 4 years
|
0 percentage of participants
Interval 0.0 to 100.0
|
50 percentage of participants
Interval 8.9 to 91.1
|
Adverse Events
Arm I: Cisplatin/Radiation Therapy
Serious events: 14 serious events
Other events: 103 other events
Deaths: 17 deaths
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Serious events: 25 serious events
Other events: 99 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Arm I: Cisplatin/Radiation Therapy
n=107 participants at risk
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
n=101 participants at risk
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
3/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
3.0%
3/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.00%
0/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
3.0%
3/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
2/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.0%
5/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
General disorders
Fever
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.00%
0/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Infections and infestations
Sepsis
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Infections and infestations
Tooth infection
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.00%
0/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
4.0%
4/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Creatinine increased
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.00%
0/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
1.9%
2/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Neutrophil count decreased
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Platelet count decreased
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
White blood cell decreased
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
2.0%
2/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.00%
0/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.00%
0/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.00%
0/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Vascular disorders
Hypertension
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.00%
0/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Vascular disorders
Lymphocele
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.99%
1/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Vascular disorders
Thromboembolic event
|
1.9%
2/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
0.00%
0/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
Other adverse events
| Measure |
Arm I: Cisplatin/Radiation Therapy
n=107 participants at risk
Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
|
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
n=101 participants at risk
Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
44.9%
48/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
59.4%
60/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
9.3%
10/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.8%
3/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.9%
6/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.8%
3/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.9%
6/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
17.8%
19/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
20.8%
21/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Eye disorders
Blurred vision
|
4.7%
5/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
7.9%
8/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
29.9%
32/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
30.7%
31/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Anal pain
|
3.7%
4/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
8.9%
9/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
37.4%
40/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
53.5%
54/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
57.9%
62/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
56.4%
57/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.0%
16/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
18.8%
19/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.5%
7/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.0%
5/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.5%
8/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.8%
3/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
66.4%
71/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
69.3%
70/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
25.2%
27/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
33.7%
34/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
General disorders
Chills
|
5.6%
6/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
3.0%
3/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
General disorders
Edema limbs
|
11.2%
12/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.0%
5/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
General disorders
Fatigue
|
54.2%
58/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
58.4%
59/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
General disorders
Fever
|
6.5%
7/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
10.9%
11/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.7%
4/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
General disorders
Pain
|
19.6%
21/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
15.8%
16/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.7%
4/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.9%
6/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
9.3%
10/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
19.8%
20/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.93%
1/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.9%
6/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
11/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
17.8%
18/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
4.7%
5/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
7.9%
8/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Creatinine increased
|
7.5%
8/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
11.9%
12/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
15.9%
17/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
21.8%
22/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Neutrophil count decreased
|
32.7%
35/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
51.5%
52/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Platelet count decreased
|
26.2%
28/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
33.7%
34/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Weight gain
|
1.9%
2/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
Weight loss
|
7.5%
8/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
9.9%
10/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Investigations
White blood cell decreased
|
42.1%
45/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
51.5%
52/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.2%
27/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
35.6%
36/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.3%
10/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
16.8%
17/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.9%
6/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.7%
5/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.5%
7/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
10.9%
11/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.2%
12/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
11.9%
12/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.8%
19/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
21.8%
22/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.2%
12/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
9.9%
10/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
8/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
11.9%
12/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
11/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
10.9%
11/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
2/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Psychiatric disorders
Depression
|
5.6%
6/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
8.9%
9/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.7%
5/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
16.8%
17/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
6/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
11.9%
12/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Nervous system disorders
Dizziness
|
11.2%
12/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
10.9%
11/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Nervous system disorders
Dysgeusia
|
2.8%
3/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
9.9%
10/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Nervous system disorders
Headache
|
16.8%
18/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
28.7%
29/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Nervous system disorders
Paresthesia
|
4.7%
5/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
18.8%
19/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.8%
3/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
9.9%
10/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.6%
22/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
48.5%
49/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Psychiatric disorders
Anxiety
|
12.1%
13/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
18.8%
19/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Psychiatric disorders
Insomnia
|
11.2%
12/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
19.8%
20/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.9%
2/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
11.9%
12/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Hematuria
|
1.9%
2/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
12.1%
13/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
7.9%
8/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
15.9%
17/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
22.8%
23/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.5%
7/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
10.9%
11/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
6.5%
7/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
10.9%
11/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Urinary tract pain
|
7.5%
8/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
21.8%
22/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Renal and urinary disorders
Urinary urgency
|
7.5%
8/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
7.9%
8/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Reproductive system and breast disorders
Dyspareunia
|
9.3%
10/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
11.9%
12/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.3%
10/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
19.8%
20/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
3.7%
4/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
8.9%
9/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.5%
8/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
7.9%
8/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
8.4%
9/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
7.9%
8/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.8%
3/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
8.9%
9/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Reproductive system and breast disorders
Vaginal pain
|
3.7%
4/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
7.9%
8/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
8/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
16.8%
17/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.3%
10/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
15.8%
16/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.4%
9/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
36.6%
37/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
9.3%
10/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.0%
5/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Vascular disorders
Hot flashes
|
20.6%
22/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
21.8%
22/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Vascular disorders
Hypertension
|
8.4%
9/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
6.9%
7/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Vascular disorders
Lymphedema
|
8.4%
9/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
9.9%
10/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
6/107 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
5.0%
5/101 • From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER