Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab
Phase 2
Terminated
- Conditions
- Patients With Gastric Peritoneal Carcinomatosis
- Interventions
- Registration Number
- NCT01784900
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Brief Summary
Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- consent form signed
- Age >= 18
- Carcinomatosis pre operative known or discivered in intraoperative
- Patients uin good general condition who may have extent surgery associated to specific inflammatory syndrom of immunotherapy
- Patients in good general condition
- Patient insured to social care
Inclusion Criteria (intraoperative):
- Gastric adenocarcinoma with macroscopic peritoneal carcinomatosis (PC) confirmed by extemporaneous histological examination
- CP extension minimal or moderate (peritoneal index ≤ 12).
- Resection of the entire macroscopic lesions detectable (primary tumor, lymph nodes and CP). cleaning D2 lymph node (or D1.5).
Exclusion Criteria
- Presence of metastasis in reach
- Previous treatment with a non-humanized monoclonal AC- (mice or rat)
- Hypersensitivity to any type of antibody.
- History of cancer within 5 years preceding the entry in the trial other than basal cell skin carcinoma or in situ of the cervix,
- Patients already included in another clinical trial with experimental molecule
- Pregnant, or likely to be or breastfeeding, (Women of childbearing potential should have a pregnancy test (blood) negative 15 days before the date of the surgery) Using of a suitable method of contraception for patients of childbearing age during treatment. adequate contraception Methods includeare: an intrauterine device, hormonal contraception, condom use combined with a spermicide
- Persons deprived of liberty or Trust (including curatorship)
- Unable to undergo medical test for geographical, social or psychological.
Exclusion Criteria (intraoperative):
- Persistent peritoneal lesions visible to the end of the surgery
- Resection of the tail of the pancreas or pancreatic break (because no drainage post-op); break pleural (for K cardia)
- Presence of metastasis in reach during surgery (except for ovarian metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Schema B (140µg) Catumaxomab 140µg * D0 : 20 μg of catumaxomab * D2 : 40 μg * D4 : 80 μg Schema A (100µg) Catumaxomab 100µg * D0 : 10 μg of catumaxomab * D2 : 30 μg * D4 : 60 μg
- Primary Outcome Measures
Name Time Method Progression Free Survival every 3 months for the first two years
- Secondary Outcome Measures
Name Time Method Progression Free Survival every 3 months for the first two years then every 4 months on year 3 then every 6 months on year 4 and 5
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, Val de Marne, France