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Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia

Primary Purpose

Colon Tumors, Rectum Tumors, Appendix Tumors

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Oxaliplatin and irinotecan

About this trial

This is an interventional treatment trial for Colon Tumors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Peritoneal seedings coming from colon, rectum, pseudomyxoma (appendix), peritoneum (mesothelioma and serous tumors), or endocrine tumors. No extra-abdominal metastases Good general status (American Society of Anesthesiologists Physical Status score [ASA] 1 or 2) Signed consent Exclusion Criteria: Tumor seedings coming from other origins Huge peritoneal carcinomatosis (peritoneal score > 25, except for pseudomyxomas) Peritoneal carcinomatosis progressing rapidly Presence of extra-abdominal metastases Patients presenting contraindications to the use of oxaliplatin or irinotecan

Sites / Locations

Institut Gustave-Roussy

Outcomes

Primary Outcome Measures

To study overall survival

Secondary Outcome Measures

To study mortality-morbidity

Full Information

NCT ID

NCT00180960

First Posted

September 13, 2005

Last Updated

September 7, 2006

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT00180960

Brief Title

Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia

Official Title

Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Terminated

Study Start Date

June 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using oxaliplatin plus irinotecan. This is a Phase II study with 100 patients. Origins of the tumors: these include colon, rectum, appendix, peritoneum, and endocrine tumors.

6. Conditions and Keywords

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

Colon Tumors, Rectum Tumors, Appendix Tumors, Peritoneum Tumors, Endocrine Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin and irinotecan

Primary Outcome Measure Information:

Title

To study overall survival

Secondary Outcome Measure Information:

Title

To study mortality-morbidity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominique Elias, MD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Gustave-Roussy

City

Villejuif

ZIP/Postal Code

94800

Country

France

12. IPD Sharing Statement

Learn more about this trial

Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia

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