Trial Outcomes & Findings for Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer (NCT NCT01041027)
NCT ID: NCT01041027
Last Updated: 2023-10-26
Results Overview
PFS will be analyzed using standard survival analytic methods, including the Kaplan-Meier approach for estimating the survival distribution. Median time to progression and 95% confidence intervals will be estimated from the Kaplan-Meier curves.
TERMINATED
PHASE2
31 participants
From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years
2023-10-26
Participant Flow
31 participants were enrolled into the study between 1/16/2009 (date the first participant was enrolled) and 6/3/2019 (date final participant was enrolled)
40 participants were recruited. Of the 40 participants, 1 participant was not consented and 8 participants screen failed. 31 participants were enrolled and randomized into the study.
Participant milestones
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiation Therapy)
CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21.
RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.
Paclitaxel: Given IV
Carboplatin: Given IV
Internal Radiation Therapy: Undergo HDR brachytherapy
External Beam Radiation Therapy: Undergo EBRT
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiation Therapy)
CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21.
RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.
Paclitaxel: Given IV
Carboplatin: Given IV
Internal Radiation Therapy: Undergo HDR brachytherapy
External Beam Radiation Therapy: Undergo EBRT
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Delayed Radiation Therapy
|
1
|
|
Overall Study
Adverse Event
|
4
|
Baseline Characteristics
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiation Therapy)
n=31 Participants
CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21.
RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.
Paclitaxel: Given IV
Carboplatin: Given IV
Internal Radiation Therapy: Undergo HDR brachytherapy
External Beam Radiation Therapy: Undergo EBRT
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until documented tumor recurrence or death from any cause, assessed up to 5 yearsPopulation: PFS data was not collected and analyzed.
PFS will be analyzed using standard survival analytic methods, including the Kaplan-Meier approach for estimating the survival distribution. Median time to progression and 95% confidence intervals will be estimated from the Kaplan-Meier curves.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: IGF-1 expression data was not collected and analyzed.
Associations of PFS with tumor tissue expression levels of IGF-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: IGF-2 expression data was not collected and analyzed.
Associations of PFS with tumor tissue expression levels of IGF-2 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: IGFBP-1 expression data was not collected and analyzed.
Associations of PFS with tumor tissue expression levels of IGFBP-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: IGFBP-3 expression data was not collected and analyzed.
Associations of PFS with tumor tissue expression levels of IGFBP-3 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Insulin receptor expression data was not collected and analyzed.
Associations of PFS with tumor tissue expression levels of insulin receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: IGF-1 receptor expression data was not collected and analyzed.
Associations of PFS with tumor tissue expression levels of IGF-1 receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Estrogen receptor expression data was not collected and analyzed.
Associations of PFS with tumor tissue expression levels of estrogen receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Progesterone receptor expression data was not collected and analyzed.
Associations of PFS with tumor tissue expression levels of progesterone receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Paclitaxel, Carboplatin, Radiation Therapy)
Serious adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiation Therapy)
n=31 participants at risk
CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21.
RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.
Paclitaxel: Given IV
Carboplatin: Given IV
Internal Radiation Therapy: Undergo HDR brachytherapy
External Beam Radiation Therapy: Undergo EBRT
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
1/31 • Number of events 4 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
2/31 • Number of events 3 • Up to 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.5%
2/31 • Number of events 2 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Catheter related infection
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
Other adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiation Therapy)
n=31 participants at risk
CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21.
RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.
Paclitaxel: Given IV
Carboplatin: Given IV
Internal Radiation Therapy: Undergo HDR brachytherapy
External Beam Radiation Therapy: Undergo EBRT
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.9%
4/31 • Number of events 9 • Up to 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.7%
3/31 • Number of events 7 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.2%
1/31 • Number of events 2 • Up to 5 years
|
|
Investigations
Alkaline Phosphatase Increased
|
3.2%
1/31 • Number of events 2 • Up to 5 years
|
|
Investigations
SGOT/SGPT ratio elevated
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
9.7%
3/31 • Number of events 3 • Up to 5 years
|
|
Investigations
Increased ALT
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
2/31 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
9.7%
3/31 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
2/31 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
Leukocytopenia
|
3.2%
1/31 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.2%
1/31 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Neuropathy (peripheral)
|
9.7%
3/31 • Number of events 4 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Ankle Pain
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Breast Pain
|
3.2%
1/31 • Number of events 2 • Up to 5 years
|
|
Investigations
Neutrophil Count Decreased
|
3.2%
1/31 • Number of events 3 • Up to 5 years
|
|
General disorders
Fatigue
|
6.5%
2/31 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Vulval Infection
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Paresthesia
|
6.5%
2/31 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Pelvic Pain
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Finger Pain
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Proctitis
|
3.2%
1/31 • Number of events 2 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal Irritation
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Upper Respiratory Infection
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Cystitis
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Investigations
Alanine Aminotransferase Increased
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Number of events 4 • Up to 5 years
|
|
Gastrointestinal disorders
Toothache
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Discoloration
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.2%
1/31 • Number of events 1 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place