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

Endocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00180960
• Other study ID #: CHIP4 Phase II
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 7, 2006
• Start date: June 2003

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendiceal Neoplasms
• Appendix Tumors
• Colon Tumors
• Endocrine Gland Neoplasms
• Endocrine Tumors
• Peritoneum Tumors
• Rectum Tumors

Intervention

Drug:
• Oxaliplatin and irinotecan

Locations

Country	Name	City	State
France	Institut Gustave-Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study overall survival
Secondary	To study mortality-morbidity