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Therapeutic Areas: Oncology
Disease Category: Endometrial Cancer

Trial Information

Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer GOG 0238

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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 giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with recurrent endometrial cancer.

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of endometrial cancer, including the following histological subtypes:
  • Adenocarcinoma
  • Adenocarcinoma with squamous differentiation
  • Mucinous adenocarcinoma
  • Squamous cell carcinoma
  • Mixed carcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
  • Serous adenocarcinoma
  • Must have undergone prior complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy
  • Recurrent disease confined to the pelvis and/or vagina
• No evidence of extrapelvic disease, including positive periaortic or inguino-femoral nodes by chest x-ray or CT scan
• Prior primary surgical debulking (including removal of gross symptomatic disease in the pelvis and/or vagina) allowed provided there is residual disease that is evaluable clinically and/or by CT scan or MRI
• Patients who have undergone prior complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT scan or MRI after resection are not eligible
• Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry

PATIENT CHARACTERISTICS:

• GOG performance status 0-2
• Life expectancy ≥ 3 months
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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 sensory or motor neuropathy > grade 1
• No septicemia or severe infection
• No circumstances that would preclude study participation
• No renal abnormalities (i.e., pelvic kidney, horseshoe kidney, or prior renal transplantation) that would require modification of radiation fields
• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
• No significant history of cardiac disease, including uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within the past 6 months
• No history of active collagen vascular disease

PRIOR CONCURRENT THERAPY:

• At least 6 months since prior hormone therapy and/or systemic chemotherapy
• No prior neoadjuvant chemotherapy for recurrent disease
• No prior exenterative surgery
• No prior vaginal, pelvic, or abdominal irradiation
• No prior chemotherapy directed at the present recurrent disease
• No prior cancer treatment that would preclude study treatment

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
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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