Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery (NCT NCT00331760)
NCT ID: NCT00331760
Last Updated: 2019-02-26
Results Overview
Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is \<= 80%. The alternative hypothesis is that the true probability is \>= 95%. For \[vagina / pelvic lymph nodes\]: UD is defined as: The 90% isodose surface covers \< 95% of \[internal target volume (ITV)/ planned target volume (PTV)\] 50.4 or \> 5% of the \[ITV/PTV\] 50.4 receives over 115%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
48
|
|
Overall Study
COMPLETED
|
43
|
40
|
|
Overall Study
NOT COMPLETED
|
15
|
8
|
Reasons for withdrawal
| Measure |
Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Overall Study
Ineligible / no protocol treatment
|
15
|
8
|
Baseline Characteristics
Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
Baseline characteristics by cohort
| Measure |
Endometrial Cancer: IMRT
n=58 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=48 Participants
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=93 Participants
|
43 years
n=4 Participants
|
53 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.Population: All eligible patients.
Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is \<= 80%. The alternative hypothesis is that the true probability is \>= 95%. For \[vagina / pelvic lymph nodes\]: UD is defined as: The 90% isodose surface covers \< 95% of \[internal target volume (ITV)/ planned target volume (PTV)\] 50.4 or \> 5% of the \[ITV/PTV\] 50.4 receives over 115%.
Outcome measures
| Measure |
Endometrial Cancer: IMRT
n=43 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 Participants
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From the start of treatment to 90 days.Population: Eligible patients who started study treatment
Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.
Outcome measures
| Measure |
Endometrial Cancer: IMRT
n=43 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 Participants
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Percentage of Patients With Grade 2+ Bowel Adverse Events
|
27.9 percentage of participants
Interval 16.6 to 42.8
|
22.5 percentage of participants
Interval 12.1 to 37.7
|
SECONDARY outcome
Timeframe: From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.Population: Eligible patients who started study treatment
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
Outcome measures
| Measure |
Endometrial Cancer: IMRT
n=43 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 Participants
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events
Non-hematologic
|
19 percentage of participants
Interval 9.0 to 33.0
|
30 percentage of participants
Interval 18.0 to 46.0
|
|
Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events
Overall
|
30 percentage of participants
Interval 19.0 to 45.0
|
48 percentage of participants
Interval 33.0 to 63.0
|
SECONDARY outcome
Timeframe: From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.Population: Eligible patients who started study treatment
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.
Outcome measures
| Measure |
Endometrial Cancer: IMRT
n=43 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 Participants
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
Non-hematologic
|
12 percentage of participants
Interval 5.0 to 25.0
|
10 percentage of participants
Interval 3.0 to 24.0
|
|
Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
Overall
|
12 percentage of participants
Interval 5.0 to 25.0
|
10 percentage of participants
Interval 3.0 to 24.0
|
SECONDARY outcome
Timeframe: From start to end of chemotherapy, approximately five weeks from registration.Population: Eligible patients in the chemotherapy group (cervical cancer patients) who started study treatment
Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.
Outcome measures
| Measure |
Endometrial Cancer: IMRT
n=40 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant
|
80 percentage of participants
Interval 65.0 to 90.0
|
—
|
SECONDARY outcome
Timeframe: From registration to five years.Population: Eligible patients who started study treatment
Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method.
Outcome measures
| Measure |
Endometrial Cancer: IMRT
n=43 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 Participants
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Rate of Local-regional Failure at Five Years
|
5 percentage of participants
Interval 1.0 to 14.0
|
8 percentage of participants
Interval 2.0 to 19.0
|
SECONDARY outcome
Timeframe: From registration to five yearsPopulation: Eligible patients who started study treatment
Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary.
Outcome measures
| Measure |
Endometrial Cancer: IMRT
n=43 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 Participants
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Rate of Distant Metastases at Five Years
|
7 percentage of participants
Interval 2.0 to 17.0
|
14 percentage of participants
Interval 5.0 to 27.0
|
SECONDARY outcome
Timeframe: From registration five yearsPopulation: Eligible patients who started study treatment
Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.
Outcome measures
| Measure |
Endometrial Cancer: IMRT
n=43 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 Participants
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Rate of Disease-free Survival at Five Years
|
88 percentage of participants
Interval 74.0 to 95.0
|
84 percentage of participants
Interval 68.0 to 92.0
|
SECONDARY outcome
Timeframe: From randomization to five yearsPopulation: Eligible patients who started study treatment
Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Outcome measures
| Measure |
Endometrial Cancer: IMRT
n=43 Participants
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 Participants
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Rate of Overall Survival at Five Years
|
88 percentage of participants
Interval 74.0 to 95.0
|
92 percentage of participants
Interval 77.0 to 97.0
|
Adverse Events
Endometrial Cancer: IMRT
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Endometrial Cancer: IMRT
n=43 participants at risk
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 participants at risk
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea NOS
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Urinary tract infection NOS
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Endometrial Cancer: IMRT
n=43 participants at risk
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
|
Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
n=40 participants at risk
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.6%
11/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
52.5%
21/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal distention
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
27.9%
12/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
10/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Anal discomfort
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
11.6%
5/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
8/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
76.7%
33/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
82.5%
33/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Enteritis
|
14.0%
6/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastritis NOS
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
32.6%
14/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
67.5%
27/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Proctitis NOS
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
35.0%
14/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
46.5%
20/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
67.5%
27/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain NOS
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Urinary tract infection NOS
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
14.0%
6/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
6/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Fracture NOS
|
4.7%
2/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Radiation recall syndrome
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
9.3%
4/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.5%
1/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Leukopenia NOS
|
39.5%
17/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
65.0%
26/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
20.9%
9/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
45.0%
18/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
16.3%
7/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
27.5%
11/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight decreased
|
9.3%
4/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.3%
4/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.5%
9/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
23.3%
10/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
7/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.6%
5/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.5%
9/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.6%
5/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
6/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.7%
2/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.6%
5/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.6%
5/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysgeusia
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
6/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
4/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.0%
6/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
6/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
16.3%
7/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
6/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Libido decreased
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Cystitis NOS
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
7/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Pollakiuria
|
23.3%
10/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
10/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urethral pain
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
20.9%
9/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
7/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
4/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Pelvic pain NOS
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
5/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Vaginal atresia
|
14.0%
6/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
35.0%
14/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
8/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
4/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Vaginal pain
|
4.7%
2/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
4/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Vaginal stricture
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Vaginitis
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
9.3%
4/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
6/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.5%
3/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
7.0%
3/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
2/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hot flushes NOS
|
9.3%
4/43
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
47.5%
19/40
Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place