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Sponsored by: |
Commissie Voor Klinisch Toegepast Onderzoek |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00376844 |
RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving external-beam radiation therapy or implant radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation when given after surgery in treating stage I endometrial cancer.
PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or implant radiation therapy to see how well they work compared with observation in treating patients who have undergone surgery for stage I endometrial cancer.
Condition | Intervention | Phase |
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Endometrial Cancer |
Procedure: adjuvant therapy Procedure: brachytherapy Procedure: observation Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy |
Estimated Enrollment: | 104 |
Study Start Date: | May 2006 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 104 patients will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of stage I endometrial cancer meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Netherlands | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC |
Study Chair: | Carien C. L. Creutzberg, MD, PhD | Leiden University Medical Center |
Study ID Numbers: | CDR0000502033, CKTO-2001-04, EU-20508 |
Study First Received: | September 13, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00376844 |
Health Authority: | United States: Federal Government |
stage I endometrial carcinoma |
Genital Diseases, Female Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases |
Uterine Neoplasms Urogenital Neoplasms Endometrial cancer Carcinoma |
Neoplasms Neoplasms by Site |