Informations générales (source: ClinicalTrials.gov)
Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Colon Peritoneal Metastases - a Multicentre Phase II Randomized Trial (PIPOX02)
Interventional
Phase 2
Institut Cancerologie de l'Ouest (Voir sur ClinicalTrials)
février 2025
août 2029
27 août 2025
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Isabelle SOUROUILLE | 07/08/2026 13:10:03 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Antoine MARIANI, MD | Contact (sur clinicalTrials) | |||
| HIA BEGIN | Anne-Cécile EZANNO, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM La Timone - 13385 - Marseille - France | Nicolas PIRRO, MD | Contact (sur clinicalTrials) | |||
| APHP Saint Louis - 75010 - Paris - France | Diane GOERE, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen - France | Sharmini VARATHARAJAH, MD | Contact (sur clinicalTrials) | |||
| Centre Georges François Leclerc - 21079 - Dijon - France | David ORRY, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier TARBES - 65013 - Tarbes - France | Amandine PINTO, Doctor | Contact (sur clinicalTrials) | |||
| CHRU - 67098 - Strasbourg - France | Cécile BRIGAND, MD | Contact (sur clinicalTrials) | |||
| CHU - 59045 - Lille - France | Clarisse EVENO, MD | Contact (sur clinicalTrials) | |||
| CHU Dupuytren - 87042 - Limoges - France | Sylvaine DURAND, MD | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Hôpital Lyon Sud - 69495 - Pierre-Bénite - France | Vahan KEPENEKIAN, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine (ICL) - 54500 - Vandoeuvre Les Nancy - France | Cécilia CERIBELLI, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Saint Herblain - 44805 - Saint HERBLAIN - France | Frédéric DUMONT, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Montpellier (ICM) - 34298 - Montpellier - France | Olivia SGABURA, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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;
- 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