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Clinical Trials (PDQ®)

Phase II Study of Whole-Abdominal Radiotherapy in Patients with Papillary Serous Carcinoma and Clear Cell Carcinoma of the Endometrium or with Maximally Debulked Advanced Endometrial Carcinoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedany ageNCIGOG-94

Objectives

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.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

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.

Expected Enrollment

Approximately 76 patients will be required; 20 patients per year are expected 
to be accrued over 4 years.

Outline

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 Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Janice H. Axelrod, MD, Protocol chair
Ph: 412-578-1819

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.

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