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Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma

NCT ID: NCT00349505

Last Updated: 2006-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Epithelial Ovarian Carcinoma Figo Stage IIIC

Keywords

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previous treatment surgery + 6 cycles of platinum based chemotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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hyper thermic chemo + surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Principal Investigators

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Dominique ELIAS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dominique ELIAS, MD, PhD

Role: CONTACT

Phone: 00 33 014-211-5441

Email: [email protected]

Annie REY

Role: CONTACT

Phone: 00 33 014-211-4137

Email: [email protected]

Facility Contacts

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Dominique ELIAS, MD,PhD

Role: primary

Other Identifiers

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CSET 1058

Identifier Type: -

Identifier Source: secondary_id

CHIPOVAC1

Identifier Type: -

Identifier Source: org_study_id