Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study (PIPAC EstoK 01)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 2

Conditions

Chemotherapy Effect

Cancer Metastatic

Gastric Adenocarcinoma

Treatments

Drug: Standard chemotherapy

Drug: Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

Study type

Interventional

Funder types

Other

Identifiers

NCT04065139

2018-004755-20 (EudraCT Number)

P160951J

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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