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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00492778 |
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.
Condition | Intervention | Phase |
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Endometrial Cancer |
Drug: cisplatin Procedure: brachytherapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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 |
Estimated Enrollment: | 210 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients undergo external-beam radiotherapy (EBRT) to the pelvis on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy* or low-dose rate interstitial brachytherapy*
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Procedure: brachytherapy
Given intracavitarily or interstitially
Procedure: radiation therapy
Given to the pelvis
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Arm II: Experimental
Patients undergo EBRT as in arm I and receive cisplatin IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Patients then undergo brachytherapy* as in arm I.
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Drug: cisplatin
Given IV
Procedure: brachytherapy
Given intracavitarily or interstitially
Procedure: radiation therapy
Given to the pelvis
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms.
NOTE: *IMRT boost is allowed for patients who are not candidates for brachytherapy.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of endometrial cancer, including the following histological subtypes:
Recurrent disease confined to the pelvis and/or vagina
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Higinia R. Cardenes, MD, PhD | Indiana University Melvin and Bren Simon Cancer Center |
Investigator: | Julian C. Schink, MD | Robert H. Lurie Cancer Center |
Investigator: | Penny Anderson, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000550975, GOG-0238 |
Study First Received: | June 25, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00492778 |
Health Authority: | Unspecified |
recurrent endometrial carcinoma endometrial adenoacanthoma endometrial adenocarcinoma |
endometrial adenosquamous cell carcinoma endometrial clear cell carcinoma endometrial papillary carcinoma |
Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Recurrence Carcinoma Genital Diseases, Female Endometrial Neoplasms |
Adenocarcinoma, Clear Cell Cisplatin Carcinoma, Papillary Uterine Neoplasms Endometrial cancer Adenocarcinoma Carcinoma, Adenosquamous |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |