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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04065139
Other study ID # P160951J
Secondary ID 2018-004755-20
Status Suspended
Phase Phase 2
First received
Last updated
Start date June 11, 2020
Est. completion date December 31, 2024

Study information

Verified date April 2022
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 66
Est. completion date December 31, 2024
Est. primary completion date February 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
France Hôpital Universitaire Claude Huriez Lille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Postoperative pain H6 Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) 6 hours after end of surgery
Secondary Postoperative pain H12 Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) 12 hours after end of surgery
Secondary Postoperative pain H18 Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) 18 hours after end of surgery
Secondary Postoperative pain H24 Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) 24 hours after end of surgery
Secondary Postoperative pain H30 Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) 30 hours after end of surgery
Secondary Postoperative pain H36 Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) 36 hours after end of surgery
Secondary Postoperative pain H42 Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) 42 hours after end of surgery
Secondary Postoperative pain H48 Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) 48 hours after end of surgery
Secondary Overall survival Progression Free survival 24 months
Secondary Secondary resectability rate Secondary resectability rate after the treatment 24 months
Secondary Quality of life Quality of life evaluated monthly by the patient with the EORTC QLQ-STO22 questionnaire monthly until death or 24 months
Secondary Quality of health status Quality of health status evaluated monthly by the patient with the EQ-5D-5L questionnaire monthly until death or 24 months
Secondary Toxicity Rate of treatment-related toxicity at 60 days of each PIPAC procedure 60 days
Secondary PIPAC success Rate of successful PIPAC procedures 24 hours
Secondary Morbidity Clavien-Dindo Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V) 60 days
Secondary Morbidity Complication Index Morbidity will be evaluated by the Comprehensive Complication Index, ranging from 0 to 100 (https://www.assessurgery.com/about_cci-calculator) 60 days
Secondary Discontinuation The time of discontinuation defined as the time from randomization to therapy change or dose reduction because of progression of disease or intolerance or adverse effects or patient refusal or death. 24 months
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