Status: Closed
Activation Date: 2000OCT18
Closing Date: 2007FEB26
Phase: III
Description: A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin for Primary Management of Low Risk Gestational Trophoblastic Neoplasia
Eligibility: Patients with untreated, histologically confirmed low risk GTN (persistent hydatidform mole or choriocarcinoma). Patients must have a pretreatment WHO score of 0 - 6 and a GOG performance status of 0 - 2.
Objective: To determine whether weekly parenteral methotrexate or "pulsed" dactinomycin is the more effective treatment for low risk gestational trophoblastic neoplasia. To prospectively determine and compare the toxicity of each regimen. To prospectively determine whether the definition of persistent GTN is accurate.
Participation: Open to member centres
Lay Description: The purpose of this study is to compare the effects (good and bad) of methotrexate compared to dactinomycin on GTN. This research is being done because we do not know which of these two commonly-used treatments is better.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GYNECOLOGIC | GT1 | 23 | 0 | 1 | 1 |
(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 | GT1 | 23 | 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 | GT1 | 23 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |