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RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel to see how well they work when given with or without cisplatin and radiation therapy in treating patients with stage III or stage IVA endometrial cancer.
- Compare the recurrence-free survival of patients with stage III or IVA endometrial carcinoma treated with adjuvant chemoradiotherapy comprising cisplatin and tumor volume-directed radiotherapy followed by carboplatin and paclitaxel vs carboplatin and paclitaxel alone.
- Compare the overall survival of patients treated with these regimens.
- Compare the acute and late adverse effects of these regimens in these patients.
- Determine the impact of these regimens on patient-reported quality of life during and for up to 1 year after completion of study treatment.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV on days 1 and 29. Patients also undergo external-beam radiotherapy once daily, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires at baseline and periodically during study using the FACT-G Physical and Functional Well-Being, FACT-Endometrial, FACT/GOG Neuropathy, and FACT-C (items C3 and C5).
After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment
carboplatin, cisplatin, paclitaxel
UAB Comprehensive Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:20:40-0400
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