- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00180960
Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia
September 7, 2006 updated by: Gustave Roussy, Cancer Campus, Grand Paris
Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Villejuif, France, 94800
- Institut Gustave-Roussy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To study overall survival
|
Secondary Outcome Measures
Outcome Measure |
---|
To study mortality-morbidity
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dominique Elias, MD, Gustave Roussy, Cancer Campus, Grand Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
September 11, 2006
Last Update Submitted That Met QC Criteria
September 7, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Cecal Diseases
- Cecal Neoplasms
- Neoplasms
- Endocrine Gland Neoplasms
- Appendiceal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Oxaliplatin
- Irinotecan
Other Study ID Numbers
- CHIP4 Phase II
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endocrine Tumors
-
Jewish General HospitalCompleted
-
University Hospital, BordeauxCompletedNeuroendocrine TumorsFrance
-
H. Lee Moffitt Cancer Center and Research InstituteGenentech, Inc.TerminatedPancreatic CancerUnited States
-
Novartis PharmaceuticalsCompletedCarcinoma | Neuroendocrine | Advanced and Metastatic Silent Neuro-Endocrine Tumors | Non Functioning Neuroendocrine Tumors (NETs) | Non Syndromic Neuroendocrine Tumors | Carcinoids | Non FunctioningSweden, Italy, Germany, United Kingdom, Spain, France, Netherlands, Poland
-
Hospices Civils de LyonRecruiting
-
IpsenCompletedEndocrine TumorsUnited States, United Kingdom, Netherlands, Belgium, Sweden, Spain, France, Denmark, India, Germany, Austria, Czechia, Italy, Poland, Slovakia
-
Hospices Civils de LyonUnknownSmall Intestine Cancer | Neuro-endocrine TumorsFrance
-
Asan Medical CenterNovartisUnknownNon Functioning Pancreatic Endocrine Tumor
-
Pamela L. KunzGenentech, Inc.TerminatedNeuroendocrine Tumors | Neuroblastoma | Multiple Endocrine Neoplasia | Pancreatic Neuroendocrine Tumors | Carcinoid Tumors | Adrenal Gland TumorsUnited States
-
Fudan UniversityQilu Hospital of Shandong University; First Affiliated Hospital Xi'an Jiaotong... and other collaboratorsRecruitingNon Functioning Pancreatic Endocrine TumorChina
Clinical Trials on Oxaliplatin and irinotecan
-
Dong-A University HospitalPusan National University Yangsan HospitalCompletedGastric CancerKorea, Republic of
-
Institut du Cancer de Montpellier - Val d'AurelleUnknownUnspecified Adult Solid Tumor, Protocol SpecificFrance
-
National Cancer Center, KoreaCompletedStomach NeoplasmsKorea, Republic of
-
National Cancer Center, KoreaUnknownColorectal Neoplasm | Secondary | Gastric NeoplasmKorea, Republic of
-
SanofiCompletedColorectal CancerUnited States, Canada, United Kingdom, Czech Republic, Hungary, Poland, Brazil
-
National Cancer Center, KoreaUnknownColorecal Neoplasms | SecondaryKorea, Republic of
-
Uppsala UniversityRecruitingColorectal Cancer | Peritoneal MetastasesSweden
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedGastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Small Intestine Cancer | Anal Cancer | Liver Cancer | Gallbladder Cancer | Extrahepatic Bile Duct Cancer | Gastrointestinal Carcinoid TumorUnited States
-
Wakayama Medical UniversityCompletedPatients With Borderline Resectable Pancreatic CancerJapan
-
Swedish Medical CenterSanofi-SynthelaboTerminated