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NCT00349505 Clinical Trial

Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma

Epithelial Ovarian Carcinoma Clinical Trial

Official title:
Phase II Study of Intra-Peritoneal Hyper-Thermic Chemotherapy as Consolidation Therapy for Advanced Epithelial Ovarian Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00349505
Other study ID # CHIPOVAC1
Secondary ID CSET 1058
Status Recruiting
Phase Phase 2
First received July 6, 2006
Last updated October 5, 2006
Start date September 2004

Study information
Verified date September 2006
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Dominique ELIAS, MD, PhD
Phone 00 33 014-211-5441
Email elias@igr.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Phase II to study results and morbidity of intra peritoneal hyper-thermic chemotherapy as consolidation therapy in patients with FIGO stage IIIC epithelial ovarian carcinoma treated by surgery and a total of 6 cycles of platinum based chemotherapy.

A second look operation is performed after treatment; during this second look secondary cytoreductive surgery is accepted without bowel resection.If none or milimetric peritoneal disease is obseved an intraperitoneal chemotherapy is achieve

Recruitment information / eligibility
Status Recruiting
Enrollment 67
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

epithelial ovarian carcinoma previous surgery + 6 cycles platinum based chemotherapy

Exclusion Criteria:

- Patients ASA 3 patients with no residual tumor at first operation negative microscopic second look

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• hyper thermic chemo + surgery

Locations
Country Name City State
France Institut Gustave Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

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