Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02)
- Conditions
- Peritoneal Metastases from Colorectal Cancer
- Interventions
- Drug: Standard Medical TherapyProcedure: PIPAC
- Registration Number
- NCT06681038
- Lead Sponsor
- Institut Cancerologie de l'Ouest
- Brief Summary
The goal of this clinical trial is to learn if Pressurized intraperitoneal aerosol chemotherapy (PIPAC) significantly improve the progression-free survival (PFS) in patients with advanced peritoneal metastasis from colorectal cancer.
Researchers will compare 2 strategies, systemic treatments (chemotherapy + targeted therapy) corresponding to standard treatment with or without intraperitoneal oxaliplatin (PIPAC) to see if PIPAC improve the progression-free survival.
Participants will:
* receive a standard treatment every 2 weeks for 12 cycles of intravenous FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF) in the both arms.
* receive up to a maximum of 4 PIPAC every 6 weeks with pressurized aerosol containing oxaliplatin in experimental arm.
* receive a maintenance treatment until progression or until the onset of severe toxicity after 12 cycles.
* be asked to perform a CT scan and carcinoembryonic antigen (CEA) assay every 8 weeks until progression
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 114
-
ECOG performance status of 0 to 2;
-
Histopathologically confirmed colonic adenocarcinoma with synchronous or metachronous peritoneal metastasis (PM);
-
Unresectable PM defined as any of the following:
- PCI >15
- Extended small bowell involvement
- Poor general condition contra-indication to a major abdominal surgery (eg: a complete cytoreductive surgery), as decided by the medico-surgical team of the investigator's site specialised in peritoneal carcinomatosis in charge of the patient.
-
A surgical exploration performed less than 4 weeks before inclusion (if not, a laparoscopic exploration must be performed);
-
First line systemic chemotherapy for advanced / metastatic colonic adenocarcinoma. Systemic chemotherapy in an adjuvant setting is allowed if completed more than 6 months before recurrence and without persistent oxaliplatin-induced neuropathy;
-
No extended intraperitoneal adherences defined by at least 9 out of 13 abdominal regions correctly explored during surgical exploration (laparoscopy or laparotomy;
- Other cancer treated within the last 3 years, with the exception of in situ cervical carcinoma or basocellular carcinoma;
- Rectal cancer primary (tumor <15 cm from the anal verge);
- Mutational status corresponding to microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR);
- Complete or partial bowel obstruction unresponsive to medical treatment;
- Extraperitoneal polymetastatic diseases. (Only oligometastatic1 diseases are allowed for inclusion);
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 6 months prior to enrolment;
- Active gastrointestinal bleeding;
- Inflammatory bowel disease;
- Peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0, grade ≥2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control ARM Standard Medical Therapy Systemic treatments Experimental ARM Standard Medical Therapy PIPAC procedure with pressurized aerosol containing oxaliplatin. Experimental ARM PIPAC PIPAC procedure with pressurized aerosol containing oxaliplatin.
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) between the two groups From randomisation to 18 months after last patient randomisation Progression free survival (PFS) is defined as the time (in months) from randomisation until the date of progression or death from any cause.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) between the two groups From randomisation to 18 months after last patient randomisation Overall survival (OS) defined as the time between randomisation and death from any cause
EORTC QLQ-C30 questionnaire At enrollment, week 16 and week 32 after the start of treatment Quality of life between the two groups evaluated by the score of EORTC QLQ-C30 questionnaire
EORTC QLQ-CR29 questionnaire At enrollment, week 16 and week 32 after the start of treatment Quality of life between the two groups evaluated by the scores of EORTC QLQ-CR29 questionnaire
Peritoneal progression free survival (PPFS) between the two groups From randomisation to 18 months after last patient randomisation Peritoneal progression free survival defined as the time between the date of randomisation and the date of peritoneal progression or death from any cause.
Obstruction-free survival (OFS) between the two groups From randomisation to 18 months after last patient randomisation Obstruction-free survival is defined as the time between the date of randomisation and the appearance of gastrointestinal obstruction requiring medication with high dose of corticosteroïd (\> 1mg/kg) or intervention as nasogastric decompression, intraluminal stenting, surgical bypass, or decompression stomy (gastrostomy or ileo/colostomy) or death.
Histological tumor response At the end of the 12th course of treatment (week 24) Peritoneal regression grading score (PRGS) on biopsies performed at surgical exploration in both groups, and systematically during 1st and 2nd PIPAC procedure.
Trial Locations
- Locations (15)
Centre François Baclesse
🇫🇷Caen, France
Centre Georges François Leclerc
🇫🇷Dijon, France
CHU
🇫🇷Lille, France
CHU Dupuytren
🇫🇷Limoges, France
APHM La Timone
🇫🇷Marseille, France
Institut de Cancérologie de Montpellier (ICM)
🇫🇷Montpellier, France
APHP Saint Louis
🇫🇷Paris, France
APHP Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hospices Civils de Lyon - Hôpital Lyon Sud
🇫🇷Pierre-Bénite, France
Institut de Cancérologie de l'Ouest - Saint Herblain
🇫🇷Saint HERBLAIN, France
Hôpital d'Instruction des Armées Bégin
🇫🇷Saint Mande, France
CHRU
🇫🇷Strasbourg, France
Centre Hospitalier TARBES
🇫🇷Tarbes, France
Institut de Cancérologie de Lorraine (ICL)
🇫🇷Vandoeuvre Les Nancy, France
Gustave Roussy
🇫🇷Villejuif, France