Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab. A Randomized Phase II Trial.
- 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
- 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).
- 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)