NCT00349505

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
Last Updated

October 6, 2006

Status Verified

September 1, 2006

First QC Date

July 6, 2006

Last Update Submit

October 5, 2006

Conditions

Epithelial Ovarian CarcinomaFigo Stage IIIC

Keywords

previous treatment surgery + 6 cycles of platinum based chemotherapy

Interventions

hyper thermic chemo + surgeryPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • epithelial ovarian carcinoma previous surgery + 6 cycles platinum based chemotherapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Dominique ELIAS, MD, PhD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique ELIAS, MD, PhD

CONTACT

00 33 014-211-5441elias@igr.fr

Annie REY

CONTACT

00 33 014-211-4137rey@igr.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 7, 2006

Study Start

September 1, 2004

Last Updated

October 6, 2006

Record last verified: 2006-09

Locations

FR(1)