NCT00807768 · OUTCOME
Number of Participants With Death Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Overall survival is measured from study enrollment for up to 10 years.
What was measured
The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study.
Analysis population: All enrolled patients.
Groups in this outcome
Arm I (Pelvic Radiation Therapy)
Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Arm II (Brachytherapy, Paclitaxel, Carboplatin)
Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
| Group | Source count |
|---|---|
| Arm I (Pelvic Radiation Therapy) | 301 |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 300 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 39 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 37 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 37
- denoms
- counts
- group Id
- OG000
- value
- 301
- group Id
- OG001
- value
- 300
- units
- Participants
- description
- The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study.
- groups
- description
- Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG000
- title
- Arm I (Pelvic Radiation Therapy)
- description
- Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG001
- title
- Arm II (Brachytherapy, Paclitaxel, Carboplatin)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All enrolled patients.
- reporting Status
- POSTED
- time Frame
- Overall survival is measured from study enrollment for up to 10 years.
- title
- Number of Participants With Death Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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