Trial Information
Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To study overall survival
Principal Investigator
Dominique Elias, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CHIP4 Phase II
NCT ID:
NCT00180960
Start Date:
June 2003
Completion Date:
Related Keywords:
- Colon Tumors
- Rectum Tumors
- Appendix Tumors
- Peritoneum Tumors
- Endocrine Tumors
- Appendiceal Neoplasms
- Colonic Neoplasms
- Endocrine Gland Neoplasms
- Peritoneal Diseases
- Rectal Neoplasms