Trial Outcomes & Findings for Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer (NCT NCT01367301)
NCT ID: NCT01367301
Last Updated: 2023-08-21
Results Overview
One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Date of entry to date of reappearance of disease, assessed at 1 year
Results posted on
2023-08-21
Participant Flow
14 participants were enrolled into the study between 7/08/2011-3/8/2016. Three participants screen failed prior to consenting.
Participant milestones
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
CHEMOTHERAPY (weeks 1-9, 14-22): 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 14-22.
RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo High Dose Rate (HDR) brachytherapy or Intensity-modulated Radiation Therapy (IMRT) once weekly during weeks 14-16.
paclitaxel: Given IV
carboplatin: Given IV
external beam radiation therapy: Undergo external beam radiation therapy
brachytherapy: Undergo HDR brachytherapy
intensity-modulated radiation therapy: Undergo IMRT
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
n=11 Participants
CHEMOTHERAPY (weeks 1-9, 14-22): 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 14-22.
RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16.
paclitaxel: Given IV
carboplatin: Given IV
external beam radiation therapy: Undergo external beam radiation therapy
brachytherapy: Undergo HDR brachytherapy
intensity-modulated radiation therapy: Undergo IMRT
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Date of entry to date of reappearance of disease, assessed at 1 yearPopulation: Recurrence-free survival data was not collected/aggregated and therefore not analyzed.
One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Radiotherapy)
n=11 participants at risk
CHEMOTHERAPY (weeks 1-9, 14-22): 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 14-22.
RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16.
paclitaxel: Given IV
carboplatin: Given IV
external beam radiation therapy: Undergo external beam radiation therapy
brachytherapy: Undergo HDR brachytherapy
intensity-modulated radiation therapy: Undergo IMRT
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
1/11 • Number of events 2 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.1%
1/11 • Number of events 1 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Infections and infestations
Urinary Tract Infection
|
9.1%
1/11 • Number of events 1 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
9.1%
1/11 • Number of events 1 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Number of events 1 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
9.1%
1/11 • Number of events 1 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
1/11 • Number of events 1 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.1%
1/11 • Number of events 1 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Infections and infestations
Papulopustular Rash
|
9.1%
1/11 • Number of events 1 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
1/11 • Number of events 1 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
1/11 • Number of events 2 • Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
|
Additional Information
Dr. Jessica Atrio, Professor, Department of Obstetrics & Gynecology and Women's Health
Albert Einstein College of Medicine - Montefiore Medical center
Phone: 917-721-6155
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place