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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00180960
Enrollment
100
Registered
2005-09-16
Start date
2003-06-30
Completion date
Unknown
Last updated
2006-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGOxaliplatin and irinotecan

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To study overall survival

Secondary

MeasureTime frame
To study mortality-morbidity

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026