Status: Closed
Activation Date: 2008SEP03
Closing Date: 2013DEC20
Phase: III
Description: Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.
Eligibility: Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO 2009 stages; confirmed at pathology review: Stage IA with myometrial invasion, grade 3 with documented lymph-vascular space invasion (LVSI); Stage IB grade 3; Stage II; Stage IIIA or IIIC; or IIIB if parametrial invasion; Stage IA with myometrial invasion, IB, II or IIIA/C with serous or clear cell histology.
Objective: Overall and failure free survival; toxicity; Quality of Life; Pelvic and distant recurrence; Translational studies on paraffin fixed tissue.
Participation: Open to member centres
Lay Description: The purpose of this study is to look at whether the benefits of radiotherapy treatment can be improved by adding chemotherapy. Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there are good scientific reasons from early clinical studies why this combination should work on endometrial cancer cells, it has not yet been tested in a large number of women with endometrial cancer. For this reason, some women will receive standard radiotherapy alone and some women will receive the new combination of radiotherapy with chemotherapy. Another purpose of this study is to find out whether the chemotherapy lengthens the effectiveness of radiotherapy, without producing side effects that interfere too much with day to day life. In order to study this we need to conduct a randomized controlled trial.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GYNECOLOGIC | EN7 | 65 | 2 | 0 | 2 |
(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 | EN7 | 65 | 1 | 52 |
| 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 | EN7 | 65 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |