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ClinicalTrials.gov ID

NCT06681038

Lead Sponsor

Institut Cancerologie de l'OuestOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

114Estimated

Last Update Posted

Nov 8, 2024Actual

Start Date

Feb 2025Estimated

Primary Completion Date

Aug 2029Estimated

Completion Date

Aug 2029Estimated

Official Title

Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Colon Peritoneal Metastases - a Multicentre Phase II Randomized Trial (PIPOX02)

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

• Peritoneal Metastases from Colorectal Cancer

• Standard Medical Therapy
• PIPAC

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Institut Cancerologie de l'OuestOTHER

dorry@cgfl.fr+33380737508

clarisse.eveno@chu-lille.fr+33320445506

sylvaine.durand-fontanier@chu-limoges.fr+33699022340

nicolas.pirro@ap-hm.fr+33491388487

diane.goere@aphp.fr+33142499718

antoine.mariani@aphp.fr+33156093562

cecile.brigand@chru-strasbourg.fr+33388126085

apinto@ch-tarbes-vic.fr

isabelle.sourrouille@gustaveroussy.fr+33142114350