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

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

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

Conditions
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Patients With Gastric Peritoneal Carcinomatosis

Intervention / Treatment
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* Drug: Catumaxomab 100µg
* Drug: Catumaxomab 140µg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schema B (140µg)<br>D0 : 20 μg of catumaxomab D2 : 40 μg D4 : 80 μg | Drug: Catumaxomab 140µg<br> <br> |
| Experimental: Schema A (100µg)<br>D0 : 10 μg of catumaxomab D2 : 30 μg D4 : 60 μg | Drug: Catumaxomab 100µg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | every 3 months for the first two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |