Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

NCT ID: NCT01709487

Last Updated: 2016-02-24

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-10-31

Brief Summary

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First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.

Detailed Description

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Addition of HIPEC to the standard first line treatment of ovarian carcinoma.

Conditions

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Ovarian Carcinoma Fallopian Tube Carcinoma Primary Peritoneal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HIPEC surgery with chemotherapy

* 3 courses of pre-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks
* Debulking surgery
* HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery
* 3 courses of post-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks

Group Type EXPERIMENTAL

HIPEC

Intervention Type PROCEDURE

HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery

Interventions

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HIPEC

HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* stage III or only pleural stage IV ovarian carcinoma first line treatment

Exclusion Criteria

* incomplete surgery poor performance status bad general condition
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jules Bordet Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Kerger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institut Jules Bordet, Brussels, Belgium.

Frédéric Goffin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hopital de la Citadelle, Liège, Belgium.

Locations

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Hopital de la Citadelle

Liège, Liège, Belgium

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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HIPEC

Identifier Type: -

Identifier Source: org_study_id

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