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

Primary Purpose

Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

HIPEC

About this trial

This is an interventional treatment trial for Ovarian Carcinoma focused on measuring HIPEC, ovarian carcinoma, Bordet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

incomplete surgery poor performance status bad general condition

Sites / Locations

Institut Jules Bordet
Hopital de la Citadelle

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIPEC surgery with chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

mortality rate

We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.

Secondary Outcome Measures

progression free survival

Overall survival

Full Information

NCT ID

NCT01709487

First Posted

October 12, 2012

Last Updated

February 23, 2016

Sponsor

Jules Bordet Institute

1. Study Identification

Unique Protocol Identification Number

NCT01709487

Brief Title

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

Official Title

Feasibility Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jules Bordet Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

Keywords

HIPEC, ovarian carcinoma, Bordet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIPEC surgery with chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

HIPEC

Intervention Description

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

Primary Outcome Measure Information:

Title

mortality rate

Description

We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

progression free survival

Time Frame

3 years

Title

Overall survival

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: stage III or only pleural stage IV ovarian carcinoma first line treatment Exclusion Criteria: incomplete surgery poor performance status bad general condition

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Kerger, M.D.

Organizational Affiliation

Institut Jules Bordet, Brussels, Belgium.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Frédéric Goffin, M.D.

Organizational Affiliation

Hopital de la Citadelle, Liège, Belgium.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Jules Bordet

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Hopital de la Citadelle

City

Liège

ZIP/Postal Code

4000

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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