Clinical Trial: Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus
Brief Summary: This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. 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, by stopping them from dividing, or by stopping them from spreading. 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.
Detailed Summary:
PRIMARY OBJECTIVES:
I. To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina.
SECONDARY OBJECTIVES:
I. To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma.
II. To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin.
III. To estimate the prognostic significance of the location (central pelvis versus vagina) and size of the recurrence, in addition to the prognostic significance in the salvage setting of the histological subtype, grade, patient age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy.
IV. To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy* or low-dose rate interstitial brachytherapy*.
ARM II: Patients undergo EBRT as in Arm I and receive cisplati
Sponsor: Gynecologic Oncology Group
Current Primary Outcome: Duration of progression-free survival [ Time Frame: From study entry until disease progression, death, or date of last contact, assessed up to 5 years ]
Original Primary Outcome: Duration of progression-free survival
Current Secondary Outcome:
- Duration of overall survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ]
- Incidence of adverse effects graded by CTCAE version 3.0 [ Time Frame: Up to 5 years ]
- Prognostic significance of tumor size, tumor location (vaginal only vs. all others) and histology [ Time Frame: Up to 5 years ]Additionally, age, race, and tumor grade will be evaluated as prognostic factors. These analyses will help to define the appropriate population with sufficient risk for future studies involving therapy that is more aggressive. A proportional hazards model adjusted for performance status and treatment will be used to explore the relationship between these variables and progression-free survival or survival.
Original Secondary Outcome: Duration of overall survival
Information By: Gynecologic Oncology Group
Dates:
Date Received: June 25, 2007
Date Started: February 2008
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016
