Clinical trial NCT04065139: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study
Official title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Adenocarcinoma
Cancer Metastatic
Chemotherapy Effect
Keywords: pressurized intraperitoneal aerosol chemotherapy (PIPAC)
gastric adenocarcinoma
metastasis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 association median survival is limited to 6 months with altered quality of life (QoL) after 4 months for all patients. We postulated that a new innovative health technology for delivering intraperitoneal pressurized aerosol of chemotherapy (Doxorubicin and Cisplatin) during laparoscopy can transform that situation offering to double the survival with QoL preservation. Interestingly, PIPAC procedure is made to be applied repeatedly, every 4 to 6 weeks. This therapeutic strategy allows to improved Intra Peritoneal (IP) drugs impregnation and maintained Intra-Veinous (IV) chemotherapy meanwhile. The primary objective of this study is to evaluate and compare 24-month progression free-survival in patients with peritoneal carcinomatosis of gastric cancer treated either with IV chemotherapy and Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) or with IV chemotherapy alone, with preservation of quality of life.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Progression Free survival
timeFrame: 24 months
Secondary outcomes:
measure: Postoperative pain H6
timeFrame: 6 hours after end of surgery
measure: Postoperative pain H12
timeFrame: 12 hours after end of surgery
measure: Postoperative pain H18
timeFrame: 18 hours after end of surgery
measure: Postoperative pain H24
timeFrame: 24 hours after end of surgery
measure: Postoperative pain H30
timeFrame: 30 hours after end of surgery
measure: Postoperative pain H36
timeFrame: 36 hours after end of surgery
measure: Postoperative pain H42
timeFrame: 42 hours after end of surgery
measure: Postoperative pain H48
timeFrame: 48 hours after end of surgery
measure: Overall survival
timeFrame: 24 months
measure: Secondary resectability rate
timeFrame: 24 months
measure: Quality of life
timeFrame: monthly until death or 24 months
measure: Quality of health status
timeFrame: monthly until death or 24 months
measure: Toxicity
timeFrame: 60 days
measure: PIPAC success
timeFrame: 24 hours
measure: Morbidity Clavien-Dindo
timeFrame: 60 days
measure: Morbidity Complication Index
timeFrame: 60 days
measure: Discontinuation
timeFrame: 24 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Universitaire Claude Huriez
Study officials:
References: