Trial Outcomes & Findings for Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix (NCT NCT00191100)
NCT ID: NCT00191100
Last Updated: 2009-08-11
Results Overview
Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted "Measure Type", so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
515 participants
Primary outcome timeframe
Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively
Results posted on
2009-08-11
Participant Flow
Participant milestones
| Measure |
Gemcitabine/Cisplatin/Radiation
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Overall Study
STARTED
|
259
|
256
|
|
Overall Study
COMPLETED
|
217
|
244
|
|
Overall Study
NOT COMPLETED
|
42
|
12
|
Reasons for withdrawal
| Measure |
Gemcitabine/Cisplatin/Radiation
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Overall Study
Adverse Event
|
18
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Patient Moved
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
3
|
|
Overall Study
Protocol Entry Criteria Not Met
|
2
|
1
|
|
Overall Study
Clinical Relapse
|
2
|
1
|
|
Overall Study
Lack of Efficacy, Progressive Disease
|
1
|
2
|
|
Overall Study
Lack of Efficacy, Stable Disease
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Death from Study Drug Toxicity
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Death from Other Cause
|
1
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
1
|
Baseline Characteristics
Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix
Baseline characteristics by cohort
| Measure |
Gemcitabine/Cisplatin/Radiation
n=259 Participants
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
n=256 Participants
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
Total
n=515 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
45.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
259 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
515.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Region of Enrollment
Pakistan
|
27 participants
n=5 Participants
|
29 participants
n=7 Participants
|
56.0 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59.0 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35.0 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67.0 participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
29 participants
n=5 Participants
|
31 participants
n=7 Participants
|
60.0 participants
n=5 Participants
|
|
Region of Enrollment
India
|
60 participants
n=5 Participants
|
56 participants
n=7 Participants
|
116.0 participants
n=5 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
33 participants
n=5 Participants
|
28 participants
n=7 Participants
|
61.0 participants
n=5 Participants
|
|
Region of Enrollment
Panama
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
61.0 participants
n=5 Participants
|
|
Grade of Histological Diagnosis
Moderately Differentiated
|
114 participants
n=5 Participants
|
119 participants
n=7 Participants
|
233.0 participants
n=5 Participants
|
|
Grade of Histological Diagnosis
Poorly Differentiated
|
48 participants
n=5 Participants
|
44 participants
n=7 Participants
|
92.0 participants
n=5 Participants
|
|
Grade of Histological Diagnosis
Unknown
|
69 participants
n=5 Participants
|
69 participants
n=7 Participants
|
138.0 participants
n=5 Participants
|
|
Grade of Histological Diagnosis
Undifferentiated
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2.0 participants
n=5 Participants
|
|
Grade of Histological Diagnosis
Well Differentiated
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50.0 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
Unknown (Missing)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1.0 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
70 - Unable to carry on normal activity
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1.0 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
80 - Activity with effort; some signs of disease
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17.0 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
90 - Normal activity; minor signs of disease
|
147 participants
n=5 Participants
|
145 participants
n=7 Participants
|
292.0 participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
100 - Normal no complaints; no evidence of disease
|
103 participants
n=5 Participants
|
101 participants
n=7 Participants
|
204.0 participants
n=5 Participants
|
|
Pathological Diagnosis
Adenocarcinoma of Cervix
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32.0 participants
n=5 Participants
|
|
Pathological Diagnosis
Adeno/Squamous Cell Carcinoma
|
198 participants
n=5 Participants
|
199 participants
n=7 Participants
|
397.0 participants
n=5 Participants
|
|
Pathological Diagnosis
Other - Poorly Differentiated Carcinoma
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1.0 participants
n=5 Participants
|
|
Pathological Diagnosis
Other - Squamous
|
43 participants
n=5 Participants
|
42 participants
n=7 Participants
|
85.0 participants
n=5 Participants
|
|
Race/Ethnicity
Western Asian
|
87 participants
n=5 Participants
|
85 participants
n=7 Participants
|
172.0 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
33 participants
n=5 Participants
|
29 participants
n=7 Participants
|
62.0 participants
n=5 Participants
|
|
Race/Ethnicity
East/Southeast Asian
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67.0 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
105 participants
n=5 Participants
|
109 participants
n=7 Participants
|
214.0 participants
n=5 Participants
|
|
Stage of Disease
Stage IIIA
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2.0 participants
n=5 Participants
|
|
Stage of Disease
Stage IIIB
|
94 participants
n=5 Participants
|
94 participants
n=7 Participants
|
188.0 participants
n=5 Participants
|
|
Stage of Disease
Stage IIB
|
160 participants
n=5 Participants
|
156 participants
n=7 Participants
|
316.0 participants
n=5 Participants
|
|
Stage of Disease
Stage IVA
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9.0 participants
n=5 Participants
|
|
Height
|
155.2 centimeters
STANDARD_DEVIATION 6.6 • n=5 Participants
|
154.6 centimeters
STANDARD_DEVIATION 6.7 • n=7 Participants
|
154.9 centimeters
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Weight
|
61.2 kilograms
STANDARD_DEVIATION 11.3 • n=5 Participants
|
62.4 kilograms
STANDARD_DEVIATION 13.0 • n=7 Participants
|
61.8 kilograms
STANDARD_DEVIATION 12.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectivelyPopulation: Intention-to-treat population includes all randomized participants. Participants were analyzed according to treatment they were randomly assigned.
Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted "Measure Type", so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented.
Outcome measures
| Measure |
Gemcitabine/Cisplatin/Radiation
n=259 Participants
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
n=256 Participants
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years
3 Years: Number of Patients with Event
|
55 participants
|
83 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years
3 Years: Number of Patients at Risk
|
149 participants
|
141 participants
|
SECONDARY outcome
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectivelyPopulation: Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.
Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented.
Outcome measures
| Measure |
Gemcitabine/Cisplatin/Radiation
n=259 Participants
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
n=256 Participants
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
3 Months: Number of Patients with Event
|
5 participants
|
8 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
3 Months: Number of Patients at Risk
|
221 participants
|
238 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
6 Months: Number of Patients with Event
|
10 participants
|
25 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
6 Months: Number of Patients at Risk
|
204 participants
|
218 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
12 Months: Number of Patients with Event
|
21 participants
|
44 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
12 Months: Number of Patients at Risk
|
186 participants
|
195 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
18 Months: Number of Patients with Event
|
24 participants
|
62 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
18 Months: Number of Patients at Risk
|
176 participants
|
170 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
24 Months: Number of Patients with Event
|
31 participants
|
69 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
24 Months: Number of Patients at Risk
|
167 participants
|
158 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
36 Months: Number of Patients with Event
|
40 participants
|
78 participants
|
|
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
36 Months: Number of Patients at Risk
|
149 participants
|
141 participants
|
SECONDARY outcome
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectivelyPopulation: Per protocol population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment actually received.
Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b).
Outcome measures
| Measure |
Gemcitabine/Cisplatin/Radiation
n=257 Participants
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
n=253 Participants
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Local Failure Rate
|
0.113 proportion of participants with PD
|
0.166 proportion of participants with PD
|
SECONDARY outcome
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectivelyPopulation: Qualified Responders population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment assigned.
Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response.
Outcome measures
| Measure |
Gemcitabine/Cisplatin/Radiation
n=256 Participants
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
n=254 Participants
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Tumor Response
Complete Response
|
223 participants
|
217 participants
|
|
Tumor Response
Partial Response
|
22 participants
|
20 participants
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause (includes 60 month follow-up period)Population: Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.
Original outcome was Overall Survival, which was defined as time from baseline to death from any cause.
Outcome measures
| Measure |
Gemcitabine/Cisplatin/Radiation
n=259 Participants
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
n=256 Participants
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Number of Participants Who Died From Any Cause at Various Time Points
18 Months: Number of Patients with Event
|
33 participants
|
46 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
18 Months: Number of Patients at Risk
|
207 participants
|
195 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
3 Months: Number of Patients with Event
|
3 participants
|
0 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
3 Months: Number of Patients at Risk
|
253 participants
|
254 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
6 Months: Number of Patients with Event
|
9 participants
|
4 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
6 Months: Number of Patients at Risk
|
241 participants
|
248 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
12 Months: Number of Patients with Event
|
22 participants
|
25 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
12 Months: Number of Patients at Risk
|
226 participants
|
222 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
24 Months: Number of Patients with Event
|
39 participants
|
58 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
24 Months: Number of Patients at Risk
|
200 participants
|
182 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
36 Months: Number of Patients with Event
|
53 participants
|
75 participants
|
|
Number of Participants Who Died From Any Cause at Various Time Points
36 Months: Number of Patients at Risk
|
175 participants
|
158 participants
|
SECONDARY outcome
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectivelyPopulation: Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.
Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause.
Outcome measures
| Measure |
Gemcitabine/Cisplatin/Radiation
n=259 Participants
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
n=256 Participants
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
12 Months: Number of Patients at Risk
|
186 participants
|
195 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
18 Months: Number of Patients with Event
|
34 participants
|
63 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
3 Months: Number of Patients with Event
|
8 participants
|
8 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
3 Months: Number of Patients at Risk
|
221 participants
|
238 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
6 Months: Number of Patients with Event
|
14 participants
|
25 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
6 Months: Number of Patients at Risk
|
204 participants
|
218 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
12 Months: Number of Patients with Event
|
29 participants
|
45 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
18 Months: Number of Patients at Risk
|
176 participants
|
170 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
24 Months: Number of Patients with Event
|
42 participants
|
72 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
24 Months: Number of Patients at Risk
|
167 participants
|
158 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
36 Months: Number of Patients with Event
|
55 participants
|
83 participants
|
|
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
36 Months: Number of Patients at Risk
|
149 participants
|
141 participants
|
Adverse Events
Gemcitabine/Cisplatin/Radiation
Serious events: 44 serious events
Other events: 259 other events
Deaths: 0 deaths
Cisplatin/Radiation
Serious events: 17 serious events
Other events: 251 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine/Cisplatin/Radiation
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
6/260 • Number of events 6
|
0.00%
0/255
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
6/260 • Number of events 6
|
0.39%
1/255 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
3/260 • Number of events 3
|
0.00%
0/255
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.77%
2/260 • Number of events 2
|
0.39%
1/255 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.5%
9/260 • Number of events 9
|
0.00%
0/255
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Eye disorders
Blindness
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
4/260 • Number of events 4
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
15/260 • Number of events 17
|
1.2%
3/255 • Number of events 3
|
|
Gastrointestinal disorders
Haematemesis
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.2%
3/260 • Number of events 3
|
1.2%
3/255 • Number of events 3
|
|
Gastrointestinal disorders
Proctitis
|
1.5%
4/260 • Number of events 4
|
0.00%
0/255
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
6/260 • Number of events 6
|
1.6%
4/255 • Number of events 4
|
|
General disorders
Oedema
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
General disorders
Pyrexia
|
1.2%
3/260 • Number of events 3
|
0.78%
2/255 • Number of events 2
|
|
Infections and infestations
Diarrhoea infectious
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Infection
|
0.38%
1/260 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Sepsis
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Infections and infestations
Urinary tract infection
|
1.2%
3/260 • Number of events 3
|
1.2%
3/255 • Number of events 3
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Investigations
Blood bilirubin
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Investigations
Blood creatinine
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Investigations
Creatinine renal clearance decreased
|
0.77%
2/260 • Number of events 2
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Dehydration
|
0.77%
2/260 • Number of events 2
|
0.39%
1/255 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
6/260 • Number of events 7
|
0.39%
1/255 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
5/260 • Number of events 5
|
0.39%
1/255 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Nervous system disorders
Leukoencephalopathy
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Renal and urinary disorders
Renal failure
|
0.38%
1/260 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Renal and urinary disorders
Urethral obstruction
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.9%
5/260 • Number of events 5
|
2.0%
5/255 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Vascular disorders
Deep vein thrombosis
|
0.77%
2/260 • Number of events 2
|
0.00%
0/255
|
|
Vascular disorders
Hypertension
|
0.38%
1/260 • Number of events 1
|
0.00%
0/255
|
|
Vascular disorders
Hypotension
|
0.00%
0/260
|
0.39%
1/255 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine/Cisplatin/Radiation
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
|
Cisplatin/Radiation
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
67.3%
175/260 • Number of events 233
|
45.1%
115/255 • Number of events 130
|
|
Blood and lymphatic system disorders
Leukopenia
|
55.8%
145/260 • Number of events 271
|
44.7%
114/255 • Number of events 124
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.9%
31/260 • Number of events 41
|
12.2%
31/255 • Number of events 32
|
|
Blood and lymphatic system disorders
Neutropenia
|
74.2%
193/260 • Number of events 378
|
29.0%
74/255 • Number of events 78
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.4%
66/260 • Number of events 79
|
11.8%
30/255 • Number of events 30
|
|
Gastrointestinal disorders
Abdominal pain
|
33.5%
87/260 • Number of events 115
|
22.4%
57/255 • Number of events 64
|
|
Gastrointestinal disorders
Constipation
|
16.9%
44/260 • Number of events 47
|
13.3%
34/255 • Number of events 36
|
|
Gastrointestinal disorders
Diarrhoea
|
61.2%
159/260 • Number of events 207
|
51.4%
131/255 • Number of events 151
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
19/260 • Number of events 19
|
5.5%
14/255 • Number of events 17
|
|
Gastrointestinal disorders
Nausea
|
64.2%
167/260 • Number of events 280
|
60.8%
155/255 • Number of events 179
|
|
Gastrointestinal disorders
Proctalgia
|
7.7%
20/260 • Number of events 22
|
6.3%
16/255 • Number of events 16
|
|
Gastrointestinal disorders
Proctitis
|
18.1%
47/260 • Number of events 52
|
9.8%
25/255 • Number of events 25
|
|
Gastrointestinal disorders
Vomiting
|
56.2%
146/260 • Number of events 248
|
47.5%
121/255 • Number of events 138
|
|
General disorders
Asthenia
|
10.8%
28/260 • Number of events 37
|
3.5%
9/255 • Number of events 9
|
|
General disorders
Fatigue
|
30.8%
80/260 • Number of events 126
|
22.4%
57/255 • Number of events 67
|
|
General disorders
Pyrexia
|
11.9%
31/260 • Number of events 38
|
8.2%
21/255 • Number of events 21
|
|
Infections and infestations
Cystitis
|
6.5%
17/260 • Number of events 19
|
3.9%
10/255 • Number of events 10
|
|
Infections and infestations
Vaginal infection
|
11.2%
29/260 • Number of events 33
|
8.6%
22/255 • Number of events 25
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
27.7%
72/260 • Number of events 77
|
25.5%
65/255 • Number of events 67
|
|
Investigations
Alanine aminotransferase
|
7.3%
19/260 • Number of events 23
|
2.7%
7/255 • Number of events 8
|
|
Investigations
Aspartate aminotransferase
|
8.5%
22/260 • Number of events 26
|
1.6%
4/255 • Number of events 4
|
|
Investigations
Creatinine renal clearance decreased
|
23.8%
62/260 • Number of events 81
|
20.0%
51/255 • Number of events 59
|
|
Metabolism and nutrition disorders
Anorexia
|
20.4%
53/260 • Number of events 61
|
17.3%
44/255 • Number of events 46
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.2%
29/260 • Number of events 34
|
11.8%
30/255 • Number of events 32
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
16/260 • Number of events 18
|
3.1%
8/255 • Number of events 9
|
|
Nervous system disorders
Headache
|
14.6%
38/260 • Number of events 47
|
9.0%
23/255 • Number of events 25
|
|
Renal and urinary disorders
Dysuria
|
36.5%
95/260 • Number of events 114
|
31.4%
80/255 • Number of events 85
|
|
Renal and urinary disorders
Pollakiuria
|
6.5%
17/260 • Number of events 17
|
5.5%
14/255 • Number of events 15
|
|
Reproductive system and breast disorders
Genital discharge
|
7.7%
20/260 • Number of events 21
|
6.7%
17/255 • Number of events 17
|
|
Reproductive system and breast disorders
Pelvic pain
|
27.3%
71/260 • Number of events 80
|
24.7%
63/255 • Number of events 68
|
|
Reproductive system and breast disorders
Vaginal discharge
|
26.9%
70/260 • Number of events 84
|
24.3%
62/255 • Number of events 62
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
56.9%
148/260 • Number of events 157
|
61.6%
157/255 • Number of events 162
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
18/260 • Number of events 18
|
5.9%
15/255 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
14/260 • Number of events 16
|
3.5%
9/255 • Number of events 9
|
|
Vascular disorders
Hypertension
|
7.3%
19/260 • Number of events 19
|
8.2%
21/255 • Number of events 21
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60