Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2029-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Peritoneal Metastases from Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control ARM

Systemic treatments

Group Type ACTIVE_COMPARATOR

Standard Medical Therapy

Intervention Type DRUG

Intravenous doublet chemotherapy FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF).

Administered every 2 weeks for 12 cycles. Dosage and administration at recommended doses.

Experimental ARM

PIPAC procedure with pressurized aerosol containing oxaliplatin.

Group Type EXPERIMENTAL

Standard Medical Therapy

Intervention Type DRUG

Intravenous doublet chemotherapy FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF).

Administered every 2 weeks for 12 cycles. Dosage and administration at recommended doses.

PIPAC

Intervention Type PROCEDURE

In addition to standard systemic treatment, patients receive also four PIPAC procedures with pressurized aerosol containing oxaliplatin.

The PIPAC procedure is repeated up to a maximum of 4 times every 6 weeks.

Interventions

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Standard Medical Therapy

Intravenous doublet chemotherapy FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF).

Administered every 2 weeks for 12 cycles. Dosage and administration at recommended doses.

Intervention Type DRUG

PIPAC

In addition to standard systemic treatment, patients receive also four PIPAC procedures with pressurized aerosol containing oxaliplatin.

The PIPAC procedure is repeated up to a maximum of 4 times every 6 weeks.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No