Status: Closed
Activation Date: 1996JUL04
Closing Date: 2005MAR31
Phase: III
Description: A Phase III Randomized Trial Comparing TAH BSO versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk, Carcinoma of the Endometrium
Eligibility: Patients with histologically confirmed adenocarcinoma of the endometrium (Stage IA [grade 3] or IB [grade 3] or IC [grade 1 or 2 or 3]) or stage IIA treated by total abdominal hysterectomy with bilateral salpingo-oophorectomy who have not received prior pelvic radiotherapy. Patients may receive first-line brachytherapy (if local standard).
Objective: In collaboration with the MRC UK ASTEC trial analysis, to compare overall survival; to evaluate the differences in recurrence-free survival, duration of pelvic control and toxicity and tolerability. Canadian components to analyse quality of life and sexual health.
Participation: Not limited
Lay Description: The purpose of this study is to compare treatment with surgery alone to treatment with radiation therapy added to the surgery. This will determine whether the addition of radiation therapy to surgery will indeed improve the outlook of patients even further. Another aim of this study is to look at a number of tests on the cancer tissue to see whether we can determine the behaviour of the cancer.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GYNECOLOGIC | EN5 | 116 | 15 | 99 | 100 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GYNECOLOGIC | EN5 | 116 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GYNECOLOGIC | EN5 | 116 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |