Clinical trial NCT06681038: Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02)
Official title: Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Colon Peritoneal Metastases - a Multicentre Phase II Randomized Trial (PIPOX02)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Peritoneal Metastases from Colorectal Cancer
Keywords: Surgical oncology
Peritoneal metastasis
Pressurized IntraPeritoneal Aerosol Chemotherapy
Systemic chemotherapy
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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;

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression free survival (PFS) between the two groups
timeFrame: From randomisation to 18 months after last patient randomisation
Secondary outcomes:
measure: Overall survival (OS) between the two groups
timeFrame: From randomisation to 18 months after last patient randomisation
measure: EORTC QLQ-C30 questionnaire
timeFrame: At enrollment, week 16 and week 32 after the start of treatment
measure: EORTC QLQ-CR29 questionnaire
timeFrame: At enrollment, week 16 and week 32 after the start of treatment
measure: Peritoneal progression free survival (PPFS) between the two groups
timeFrame: From randomisation to 18 months after last patient randomisation
measure: Obstruction-free survival (OFS) between the two groups
timeFrame: From randomisation to 18 months after last patient randomisation
measure: Histological tumor response
timeFrame: At the end of the 12th course of treatment (week 24)
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: CHU
city: Limoges
country: France
facility: CHU Dupuytren
city: Marseille
country: France
facility: APHM La Timone
city: Montpellier
country: France
facility: Institut de Cancérologie de Montpellier (ICM)
city: Paris
country: France
facility: APHP Saint Louis
city: Paris
country: France
facility: APHP Hôpital Européen Georges Pompidou
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon - Hôpital Lyon Sud
city: Saint HERBLAIN
country: France
facility: Institut de Cancérologie de l'Ouest - Saint Herblain
city: Saint Mande
country: France
facility: Hôpital d'Instruction des Armées Bégin
city: Strasbourg
country: France
facility: CHRU
city: Tarbes
country: France
facility: Centre Hospitalier TARBES
city: Vandoeuvre Les Nancy
country: France
facility: Institut de Cancérologie de Lorraine (ICL)
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Frédéric DUMONT, MD
role: PRINCIPAL_INVESTIGATOR
References: