NCT00180960

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 11, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

September 7, 2006

Conditions

Colon TumorsRectum TumorsAppendix TumorsPeritoneum TumorsEndocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • To study overall survival

Secondary Outcomes (1)

  • To study mortality-morbidity

Interventions

Oxaliplatin and irinotecanDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave-Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsAppendiceal Neoplasms

Interventions

OxaliplatinIrinotecan

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCecal NeoplasmsCecal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Dominique Elias, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2003

Last Updated

September 11, 2006

Record last verified: 2006-09

Locations

FR(1)