A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed By Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of endometrial carcinoma, meeting 1 of the following criteria:

- Stage I disease with high-intermediate risk factors with positive or negative
cytology (e.g., grade 2 or 3 tumor, presence of lymphovascular space invasion,
and/or outer half myometrial invasion), meeting 1 of the following criteria:

- Age ≥ 70 years with 1 risk factor

- Age ≥ 50 years with 2 risk factors

- Age ≥ 18 years with 3 risk factors

- Stage II (occult or gross involvement) disease (any histology) with or without
risk factors

- Occult disease is defined as lesions that are identified as an incidental
finding after hysterectomy in the absence of gross cervical disease

- Stage I-II disease with serous or clear cell histology with or without other
risk factors allowed provided the disease is uterine-confined (with or without
cervical stromal invasion or endocervical glandular involvement), and with
peritoneal cytology negative for malignancy

- Has undergone hysterectomy and bilateral salpingo-oophorectomy (laparotomy or
laparoscopic approach, including robot-assisted) with or without pelvic and
para-aortic lymphadenectomy within the past 4-12 weeks

- If nodal dissection was not performed, pelvic and para-aortic nodes must be
clinically negative with no evidence of distant disease by post-operative,
pre-treatment CT scan/MRI

- Suspicious nodes that have been biopsied (re-staging surgery, fine-needle
aspiration) allowed provided they are pathologically negative

- No pathologically confirmed spread of disease to pelvic or para-aortic lymph
nodes or adnexal structures, and/or other anatomic sites, or serous or clear
cell histology and positive cytologic washings

- No recurrent disease

- No surgical or clinical stage III or IV endometrial carcinoma

- No sarcoma, carcinosarcoma (i.e., malignant mixed mullerian tumor), or non-epithelial
uterine malignancies (i.e., leiomyosarcoma of the uterine corpus)

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mcl

- Platelet count ≥ 100,000/mcl

- Serum creatinine normal OR creatinine clearance > 50 mL/min

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- No neuropathy (sensory or motor) > grade 1

- No other invasive malignancy within the past 5 years except non-melanoma skin cancer

- No contraindications to pelvic radiotherapy (e.g., pelvic kidney, connective tissue
disease, or inflammatory bowel disease)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior non-surgical therapy for endometrial cancer, including chemotherapy,
radiotherapy (e.g., pre-operative or post-operative brachytherapy), hormonal therapy,
or biological therapy

- No prior systemic chemotherapy or radiotherapy for another malignancy

- No concurrent whole-abdominal, extended-field, or interstitial radiotherapy

- No concurrent erythropoietin therapy

- Concurrent enrollment on GOG-0210 (molecular marker study) allowed