|Phase II||Treatment||Closed||any age||NCI||GOG-94|
I. Determine the survival and progression-free interval of patients with maximally debulked advanced endometrial carcinoma treated with total abdominal radiotherapy. II. Determine the progression-free interval and site of recurrence in patients with papillary serous carcinoma and clear cell carcinoma of the endometrium treated with total abdominal radiotherapy with a pelvic boost.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients of any age with clinically and/or surgically staged primary endometrial carcinoma as follows: any stage clear cell carcinoma (clear cell histology representing more than 50% of the tumor), or any stage papillary serous carcinoma (papillary serous histology representing more than 50% of tumor). Distant metastases outside the abdomen exclude, including gross metastasis to the vagina or metastasis to the parenchymal liver or lung; microsocopic involvement of retroperitoneal nodes is permitted, as are positive para-aortic nodes provided scalene nodes are negative. Patients classified surgically as Stage III solely on the basis of positive cytologic washings and/or positive pelvic nodes are ineligible. Tumor must be maximally debulked to 2 cm or less, and surgery must have included a total abdominal hysterectomy, bilateral salpingo-oophorectomy, pelvic washings, and selective pelvic and para-aortic lymph node sampling; entry must be within 8 weeks of surgery. Prior therapy with progestational agents is permitted, but prior chemotherapy or prior pelvic or abdominal radiotherapy excludes. A GOG performance status of 3 or better is required, as are the following parameters of organ function: WBC at least 3,000, platelets at least 100,000, and granulocytes at least 1,500; creatinine no more than 2.0 mg/dl; and bilirubin and SGOT each no more than twice normal. Patients with a previous or concomitant malignancy other than nonmelanomatous skin cancer are ineligible.
Approximately 76 patients will be required; 20 patients per year are expected to be accrued over 4 years.
Nonrandomized study. Radiotherapy. Whole-abdominal irradiation using megavoltage equipment (Co60 to 25-MeV photons).Published Results
Sutton G, Axelrod JH, Bundy BN, et al.: Adjuvant whole abdominal irradiation in clinical stages I and II papillary serous or clear cell carcinoma of the endometrium: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol 100 (2): 349-54, 2006.[PUBMED Abstract]
Trial Lead Organizations
Gynecologic Oncology Group
|Janice H. Axelrod, MD, Protocol chair|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.