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

Primary Purpose

Patients With Gastric Peritoneal Carcinomatosis

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Catumaxomab 100µg
Catumaxomab 140µg
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Gastric Peritoneal Carcinomatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Schema B (140µg)

Schema A (100µg)

Arm Description

D0 : 20 μg of catumaxomab D2 : 40 μg D4 : 80 μg

D0 : 10 μg of catumaxomab D2 : 30 μg D4 : 60 μg

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Progression Free Survival

Full Information

First Posted
February 4, 2013
Last Updated
January 25, 2017
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01784900
Brief Title
Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab
Acronym
IIPOP
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Gastric Peritoneal Carcinomatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schema B (140µg)
Arm Type
Experimental
Arm Description
D0 : 20 μg of catumaxomab D2 : 40 μg D4 : 80 μg
Arm Title
Schema A (100µg)
Arm Type
Experimental
Arm Description
D0 : 10 μg of catumaxomab D2 : 30 μg D4 : 60 μg
Intervention Type
Drug
Intervention Name(s)
Catumaxomab 100µg
Intervention Type
Drug
Intervention Name(s)
Catumaxomab 140µg
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
every 3 months for the first two years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Val de Marne
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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

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