Status: Closed
Activation Date: 2001OCT19
Closing Date: 2004JAN17
Phase: III
Description: Phase III trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/L with Erythropoietin Versus Above 100 g/L without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer
Eligibility: Patients with primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Stage II-B, III-B, IV-A.
Objective: To assess the efficacy of raising and maintaining patient hemoglobin level above 120 g/L using erythropoietin compared to maintenance level above 100 g/L without erythropoietin on progression-free survival, overall survival and local control in anemic patients with carcinoma of the cervix receiving concurrent radiation and cisplatin treatment.
Participation: Open to member centres
Lay Description: The purpose of this study is to find out if raising your hemoglobin level with Eprex will improve the outcome of cervix cancer, as compared to the standard treatment which is given without Eprex, where transfusions may be used if necessary to maintain the hemoglobin.
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
GYNECOLOGIC | CX4 | 19 | 0 | 0 | 0 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
GYNECOLOGIC | CX4 | 19 | 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 | CX4 | 19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |