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Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Institut Gustave Roussy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00349505
First received: July 6, 2006
Last updated: October 5, 2006
Last verified: September 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Epithelial Ovarian Carcinoma
Figo Stage IIIC
 Procedure: hyper thermic chemo + surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Intra-Peritoneal Hyper-Thermic Chemotherapy as Consolidation Therapy for Advanced Epithelial Ovarian Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Estimated Enrollment: 67
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349505

Contacts
Contact: Dominique ELIAS, MD, PhD 00 33 014-211-5441 elias@igr.fr
Contact: Annie REY 00 33 014-211-4137 rey@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Dominique ELIAS, MD,PhD     00 33 014-211-5441     elias@igr.fr    
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Dominique ELIAS, MD, PhD Institut Gustave Roussy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00349505     History of Changes
Other Study ID Numbers: CHIPOVAC1, CSET 1058
Study First Received: July 6, 2006
Last Updated: October 5, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Gustave Roussy:
previous treatment surgery + 6 cycles of platinum based chemotherapy

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on June 13, 2013