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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Patients With Gastric Peritoneal Carcinomatosis

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Trial Information

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


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

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

every 3 months for the first two years

Safety Issue:

No

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2012-000475-17

NCT ID:

NCT01784900

Start Date:

November 2012

Completion Date:

November 2019

Related Keywords:

  • Patients With Gastric Peritoneal Carcinomatosis
  • Carcinoma

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