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

NCT06681038 | Not Yet Recruiting Phase 2

• 1 other identifier: ICO-2023-14
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 15

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

Conditions

Peritoneal Metastases from Colorectal Cancer

Keywords

Surgical oncology; Peritoneal metastasis; Pressurized IntraPeritoneal Aerosol Chemotherapy; Systemic chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) between the two groups

  Progression free survival (PFS) is defined as the time (in months) from randomisation until the date of progression or death from any cause.

  From randomisation to 18 months after last patient randomisation

Secondary Outcomes (6)

• Overall survival (OS) between the two groups

  From randomisation to 18 months after last patient randomisation

• EORTC QLQ-C30 questionnaire

  At enrollment, week 16 and week 32 after the start of treatment

• EORTC QLQ-CR29 questionnaire

  At enrollment, week 16 and week 32 after the start of treatment

• Peritoneal progression free survival (PPFS) between the two groups

  From randomisation to 18 months after last patient randomisation

• Obstruction-free survival (OFS) between the two groups

  From randomisation to 18 months after last patient randomisation

Study Arms (2)

Control ARM

ACTIVE COMPARATOR

Systemic treatments

Drug: Standard Medical Therapy

Experimental ARM

EXPERIMENTAL

PIPAC procedure with pressurized aerosol containing oxaliplatin.

Drug: Standard Medical Therapy; Procedure: PIPAC

Interventions

Standard Medical Therapy 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.

Control ARM; Experimental ARM

PIPAC 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.

Experimental ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (15)

Centre François Baclesse

Caen, 14076, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

CHU

Lille, 59045, France

Location

CHU Dupuytren

Limoges, 87042, France

Location

APHM La Timone

Marseille, 13385, France

Location

Institut de Cancérologie de Montpellier (ICM)

Montpellier, 34298, France

Location

APHP Saint Louis

Paris, 75010, France

Location

APHP Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hospices Civils de Lyon - Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut de Cancérologie de l'Ouest - Saint Herblain

Saint-Herblain, 44805, France

Location

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, 94160, France

Location

CHRU

Strasbourg, 67098, France

Location

Centre Hospitalier TARBES

Tarbes, 65013, France

Location

Institut de Cancérologie de Lorraine (ICL)

Vandœuvre-lès-Nancy, 54500, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Study Officials

• Frédéric DUMONT, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric DUMONT, MD

CONTACT

+33240679900; frederic.dumont@ico.unicancer.fr

Emilie DEBEAUPUIS

CONTACT

+33240679844; emilie.debeaupuis@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

FR (15)