Back to resultsIntraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma
Primary Purpose
Epithelial Ovarian Carcinoma, Figo Stage IIIC
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
hyper thermic chemo + surgery
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Ovarian Carcinoma focused on measuring previous treatment surgery + 6 cycles of platinum based chemotherapy
Eligibility Criteria
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
Sites / Locations
- Institut Gustave RoussyRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00349505
First Posted
July 6, 2006
Last Updated
October 5, 2006
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00349505
Brief Title
Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma
Official Title
Phase II Study of Intra-Peritoneal Hyper-Thermic Chemotherapy as Consolidation Therapy for Advanced Epithelial Ovarian Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Carcinoma, Figo Stage IIIC
Keywords
previous treatment surgery + 6 cycles of platinum based chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
hyper thermic chemo + surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique ELIAS, MD, PhD
Phone
00 33 014-211-5441
Email
elias@igr.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Annie REY
Phone
00 33 014-211-4137
Email
rey@igr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique ELIAS, MD, PhD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique ELIAS, MD,PhD
Phone
00 33 014-211-5441
Email
elias@igr.fr
12. IPD Sharing Statement
Learn more about this trial
Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma
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