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

NCT04065139 | Completed Phase 2 DMC

• 2 other identifiers: P160951J2018-004755-20
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

pressurized intraperitoneal aerosol chemotherapy (PIPAC); gastric adenocarcinoma; metastasis

Outcome Measures

Primary Outcomes (1)

• Progression Free survival

  24-month progression free-survival, defined as time from randomization to any clinical (ascites, abdominal pain, weight loss \> 10% of total body weight) and/or morphological signs (systemic metastases, ascites, progression with RECIST criteria) of recurrence (local or systemic) or death.

  24 months

Secondary Outcomes (17)

• Postoperative pain H6

  6 hours after end of surgery

• Postoperative pain H12

  12 hours after end of surgery

• Postoperative pain H18

  18 hours after end of surgery

• Postoperative pain H24

  24 hours after end of surgery

• Postoperative pain H30

  30 hours after end of surgery

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Drug: Standard chemotherapy

Experimental Arm : PIPAC

EXPERIMENTAL

Drug: Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

Interventions

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) 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.

Experimental Arm : PIPAC

Standard chemotherapy DRUG

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Universitaire Claude Huriez

Lille, 59000, France

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 22, 2019
• Study Start: June 11, 2020
• Primary Completion: March 2, 2024
• Study Completion: March 2, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

FR (1)