Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab (IIPOP)

Gustave Roussy

Status and phase

Terminated

Phase 2

Conditions

Patients With Gastric Peritoneal Carcinomatosis

Treatments

Drug: Catumaxomab 140µg

Drug: Catumaxomab 100µg

Study type

Interventional

Funder types

Other

Identifiers

NCT01784900

2012-000475-17

2011/1793 (Other Identifier)

Details and patient eligibility

About

Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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