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Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00349505
First received: July 6, 2006
Last updated: October 5, 2006
Last verified: September 2006
  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:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Estimated Enrollment: 67
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349505

Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Dominique ELIAS, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

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 Gustave Roussy, Cancer Campus, Grand Paris:
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 December 07, 2016