Status:
COMPLETED
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Gastric Adenocarcinoma
Cancer Metastatic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Peritoneal metastasis is a common pattern in advanced gastric cancer leading to a terminal condition in a very short time. Whatever recent progress regarding systemic chemotherapy using multi drugs as...
Eligibility Criteria
Inclusion
- 18 \< age ≤ 75 years
- Performance status (WHO) \< 2
- White blood cells \> 3.500 /mm3; neutrophils \> 1.500 /mm3; platelets \> 100.000 /mm3
- Creatinemia \< 1.5 x Normal, Normal ASAT, ALAT and Serum total bilirubin, Normal ionic balance (potassium, calcium, magnesium and phosphorus
- An acceptable nutritional condition with Body Mass Index (BMI) \> 18.5 kg/m2, Albumin \> 30 g/l, pre-albumin \> 110 mg/l
- Effective contraception for patients of childbearing age
- Written consent obtained prior any act of the research
- Patient with social insurance
- Patient having synchronous or metachronous peritoneal metastasis or ovarian metastasis of a gastric adenocarcinoma cancer, including adenocarcinoma with independent cells (ADCI) or linitis
- Patients with or without primary gastric tumor could be included
- Peritoneal Cancer Index (PCI) \> 8
Exclusion
- Weight loss \> 20% of total body weight before disease
- Presence of uncontrolled comorbidities including severe chronic disease or organ insufficiency
- Contraindication to any drug contained in the chemotherapy regimen, according to summary of product characteristic's
- Having any form of previous intra-abdominal chemotherapy or intra-abdominal antibody therapy
- Patients with history of allergic reactions to platinum compounds or doxorubicin
- Complete deficiency of the enzyme dihydropyrimidine dehydrogenase.
- Patients are not allowed to undergo any cancer-specific treatment during the trial.
- Secondary debulking surgery is not allowed during PIPAC treatment
- Pregnancy or breastfeeding
- Patient under guardianship
- Other systemic metastases (liver, lung, bone, brain) or lombo-aortic lymph node involvement
- Pleural effusion requiring evacuation for respiratory failure
- Small bowel occlusion with no possible food intake
- Ascites \> 3 liters
- HER2 +++ tumor
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04065139
Start Date
June 11 2020
End Date
March 2 2024
Last Update
September 19 2024
Active Locations (1)
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1
Hôpital Universitaire Claude Huriez
Lille, France, 59000