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Therapeutic Areas: Oncology
Disease Category: Endometrial Cancer

Trial Information

Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether pelvic radiation therapy is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.

PURPOSE: This randomized phase III trial is studying pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer.

Inclusion Criteria

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)

Exclusion Criteria

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

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education at Memorial Health University Medical Center
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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