Patients With Gastric Peritoneal CarcinomatosisPhase 2IIPOPNCT01784900
Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab
A Phase 2 study testing Catumaxomab 100µg and Catumaxomab 140µg in people with Patients With Gastric Peritoneal Carcinomatosis, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Gastric Peritoneal Carcinomatosis
- What is being tested?
- Catumaxomab 100µg and Catumaxomab 140µg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- Persons deprived of liberty or Trust (including curatorship)
- Unable to undergo medical test for geographical, social or psychological.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis
- Being tested
- Catumaxomab 100µg, Catumaxomab 140µg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catumaxomab 100µgDrug
Catumaxomab 140µgDrug
| Study group | Role | What they receive |
|---|---|---|
| Schema B (140µg) | Experimental | * D0 : 20 μg of catumaxomab
* D2 : 40 μg
* D4 : 80 μg Receives: Drug: Catumaxomab 140µg |
| Schema A (100µg) | Experimental | * D0 : 10 μg of catumaxomab
* D2 : 30 μg
* D4 : 60 μg Receives: Drug: Catumaxomab 100µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: every 3 months for the first two years
Secondary outcomes (1)
Progression Free Survival
Measured: every 3 months for the first two years then every 4 months on year 3 then every 6 months on year 4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Gastric Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784900
- Sponsor's protocol ID
- 2012-000475-17
- Other IDs
- 2011/1793
- Acronym
- IIPOP
- Status last verified
- Jan 2017
- First submitted
- 4 Feb 2013
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01784900
- Acronym / sponsor ID
- IIPOP / 2012-000475-17
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schema B (140µg) | Experimental | Drug: Catumaxomab 140µg* D0 : 20 μg of catumaxomab * D2 : 40 μg * D4 : 80 μg |
| Schema A (100µg) | Experimental | Drug: Catumaxomab 100µg* D0 : 10 μg of catumaxomab * D2 : 30 μg * D4 : 60 μg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catumaxomab 100µg | Drug | Schema A (100µg) |
| Catumaxomab 140µg | Drug | Schema B (140µg) |
Primary outcome
Progression Free Survival
Time frame: every 3 months for the first two years
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Catumaxomab 100µg and Catumaxomab 140µg in people with Patients With Gastric Peritoneal Carcinomatosis, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: every 3 months for the first two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.