Clinical trial NCT01784900: Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab
Official title: Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab. A Randomized Phase II Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Patients With Gastric Peritoneal Carcinomatosis
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: every 3 months for the first two years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: every 3 months for the first two years then every 4 months on year 3 then every 6 months on year 4 and 5
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val de Marne
Study officials:
References: