Status: Closed
Activation Date: 2009SEP11
Closing Date: 2015MAY27
Phase: II
Description: A Phase II Study of Intraperitoneal (IP) Plus Intravenous (IV) Chemotherapy Versus IV Carboplatin Plus Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Surgery Following Neoadjuvant Intravenous Chemotherapy.
Eligibility: Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Carcinoma
Objective: 9 month progression rate following randomization Progression-Free Survival, Overall Survival, Toxic Effects, Quality of Life
Participation: Open to member centres
Lay Description: There are two main reasons why this study is being done. The first reason is to see if in patients who first receive chemotherapy, followed by surgery and then need more chemotherapy, whether this post-surgery chemotherapy is best given as IP treatment or as IV treatment. The second reason for the study is to find out whether it is better to give IP treatment with carboplatin or cisplatin.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GYNECOLOGIC | OV21 | 275 | 17 | 43 | 59 |
(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 | OV21 | 275 | 2 | 28 |
| 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 | OV21 | 275 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |