SCCA Gynecologic Cancer Clinical Trials

DISEASE CHARACTERISTICS:

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

  • Stage I-IIA disease with high-intermediate risk factors (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 IIB (occult) 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-IIB (occult) disease with serous or clear cell histology with or without other risk factors

• Has undergone hysterectomy and bilateral salpingo-oophorectomy (open or laparoscopic approach) 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, gross disease to the cervix, or 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 nonmelanoma 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