A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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