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

NCT ID: NCT04065139

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2024-03-02

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.

Conditions

Gastric Adenocarcinoma; Cancer Metastatic; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Arm

Group Type: ACTIVE_COMPARATOR

Standard chemotherapy

Intervention Type: DRUG

Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.

Experimental Arm : PIPAC

Group Type: EXPERIMENTAL

Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

Intervention Type: DRUG

After insufflation of a 12 mmHg of capnoperitoneum at 37°C, two balloons safety trocars (10 and 12mm) are inserted into the abdominal wall. Injection of Doxorubicin (2.1 mg/m2 in 50 ml NaCl 0.9%) and Cisplatin (10.5 mg/m2 body surface in 150 ml NaCl 0.9%) with a flow rate of 0.7ml/s, the therapeutic capnoperitoneum is maintained for 30 min at body temperature.

Interventions

Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

After insufflation of a 12 mmHg of capnoperitoneum at 37°C, two balloons safety trocars (10 and 12mm) are inserted into the abdominal wall. Injection of Doxorubicin (2.1 mg/m2 in 50 ml NaCl 0.9%) and Cisplatin (10.5 mg/m2 body surface in 150 ml NaCl 0.9%) with a flow rate of 0.7ml/s, the therapeutic capnoperitoneum is maintained for 30 min at body temperature.

Intervention Type: DRUG

Standard chemotherapy

Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Universitaire Claude Huriez

Lille, , France

Countries

France

Other Identifiers

2018-004755-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P160951J

Identifier Type: -

Identifier Source: org_study_id