Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT00003749|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
RATIONALE: Lymphadenectomy may remove cancer cells that have spread to nearby lymph nodes. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether conventional surgery is more effective with or without lymphadenectomy and/or radiation therapy in treating endometrial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with or without lymphadenectomy and/or radiation therapy in treating patients who have endometrial cancer.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Procedure: adjuvant therapy Procedure: conventional surgery Radiation: brachytherapy Radiation: radiation therapy||Phase 3|
- Compare the effects of conventional surgery alone and conventional surgery plus lymphadenectomy in patients with endometrial cancer preoperatively thought to be confined to the uterine corpus.
- Determine the effect of postoperative adjuvant external beam radiotherapy on quality of life and survival of a subset of these patients at high risk of relapse and with no macroscopic disease after surgery.
OUTLINE: This is a randomized, multicenter study. Patients are randomized in both the surgery and radiotherapy segments of the study.
Surgery: Patients are randomized to 1 of 2 surgery arms.
- Arm I: Patients undergo conventional surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy).
- Arm II: Patients undergo conventional surgery as in arm I followed by lymphadenectomy with systematic dissection of the iliac and obturator nodes.
Radiotherapy: Patients at high risk of relapse who have no postoperative macroscopic disease are randomized to 1 of 2 radiotherapy arms. (Patients may enter the radiotherapy randomization after surgery off study.)
- Arm I: Patients receive in 20-25 fractions of external beam radiotherapy (total dose of 40-46 Gy) over 4-5 weeks.
- Arm II: Patients receive no external beam radiotherapy. NOTE: Some patients receive vault brachytherapy regardless of radiotherapy randomization.
Quality of life is assessed before therapy and at 2 and 5 years after therapy.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A minimum of 1400 patients will be accrued for the surgical component of this study and at least 900 patients (including additional patients not participating in the surgical component of this study) will be accrued for the radiotherapy component of this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2300 participants|
|Official Title:||A Randomised Trial of Lymphadenectomy and of Adjuvant External Beam Radiotherapy in the Treatment of Endometrial Cancer|
|Study Start Date :||April 1998|
|Actual Study Completion Date :||December 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003749
|Medical Research Council Clinical Trials Unit|
|London, England, United Kingdom, NW1 2DA|
|Royal Marsden NHS FoundationTrust - London|
|London, England, United Kingdom, SW3 6JJ|
|St. Mary's Hospital|
|Manchester, England, United Kingdom, M13 0JH|
|OverallOfficial:||Claire Amos||Medical Research Council|