- Compare the recurrence-free survival of patients with stage I-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.
- Histologically confirmed endometrial carcinoma, including the following cell types:
- Clear cell carcinoma
- Serous papillary carcinoma
- Undifferentiated carcinoma
- Surgical stage III or IVA disease per FIGO 2009 staging criteria
- Surgical stage III disease includes positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
- Surgical stage IVA disease includes bladder or bowel mucosal involvement, but no spread outside the pelvis
- Surgical stage I or II endometrial clear cell or serous papillary carcinoma with positive peritoneal cytology per FIGO 2009 staging criteria
- Has undergone optimal surgical debulking that included a hysterectomy and bilateral salpingo-oophorectomy within the past 8 weeks
- Residual tumor after surgery (any single site) ≤ 2 cm in maximum dimension
- No carcinosarcoma
- No parenchymal liver metastases
- No recurrent endometrial cancer or endometrioid stage I or II with positive peritoneal cytology
- GOG performance status 0-2
- Life expectancy ≥ 3 months
- WBC ≥ 3,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ ULN
- No myocardial infarction, unstable angina, or uncontrolled arrhythmia within the past 3 months
- No other active invasive malignancy within the past 5 years except for non-melanoma skin cancer
- No history of serious co-morbid or uncontrolled illness that would preclude study therapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic or abdominal radiotherapy
- No prior chemotherapy for endometrial cancer
- No prior cancer treatment that would preclude study therapy
Last updated: 03/26/2012