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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01784900
• Date of registration: 04/02/2013
• Prospective Registration: No
• Primary sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Public title: Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab IIPOP
• Scientific 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.
• Date of first enrolment: November 2012
• Target sample size: 26
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01784900
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Patients With Gastric Peritoneal Carcinomatosis

Intervention(s)

Drug: Catumaxomab 100µg

Drug: Catumaxomab 140µg

Primary Outcome(s)

Progression Free Survival [Time Frame: every 3 months for the first two years]

Secondary Outcome(s)

Progression Free Survival [Time Frame: every 3 months for the first two years then every 4 months on year 3 then every 6 months on year 4 and 5]

Secondary ID(s)

2011/1793

2012-000475-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors