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Peritoneal Metastases from Colorectal CancerPhase 2PIPOX02NCT06681038

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

A Phase 2 study testing Standard Medical Therapy and PIPAC in people with Peritoneal Metastases from Colorectal Cancer, run by Institut Cancerologie de l'Ouest at 15 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard Medical Therapy and PIPAC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
15 sitesFrance
Study dates
Feb 2025to Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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;

Who cannot join

  • 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;
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  • Active gastrointestinal bleeding;
  • Inflammatory bowel disease;
  • Peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0, grade ≥2

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Frédéric DUMONT, MD contact

+33240679900

frederic.dumont@ico.unicancer.fr

Emilie DEBEAUPUIS contact

+33240679844

emilie.debeaupuis@ico.unicancer.fr

15 sites in 1 country

France15 sites

  • Centre François Baclesse

    Caen, 14076

    Sharmini VARATHARAJAH, MD, +33231455002, s.varatharajah@baclesse.unicancer.fr

    Sharmini VARATHARAJAH, MD

  • Centre Georges François Leclerc

    Dijon, 21079

    David ORRY, MD, +33380737508, dorry@cgfl.fr

    David ORRY, MD

  • CHU

    Lille, 59045

    Clarisse EVENO, MD, +33320445506, clarisse.eveno@chu-lille.fr

    Clarisse EVENO, MD

  • CHU Dupuytren

    Limoges, 87042

    Sylvaine DURAND, MD, +33699022340, sylvaine.durand-fontanier@chu-limoges.fr

    Sylvaine DURAND, MD

  • APHM La Timone

    Marseille, 13385

    Nicolas PIRRO, MD, +33491388487, nicolas.pirro@ap-hm.fr

    Nicolas PIRRO, MD

  • Institut de Cancérologie de Montpellier (ICM)

    Montpellier, 34298

    Olivia SGABURA, MD, +33467613103, olivia.sgarbura@icm.unicancer.fr

    Olivia SGABURA, MD

  • APHP Saint Louis

    Paris, 75010

    Diane GOERE, MD, +33142499718, diane.goere@aphp.fr

    Diane GOERE, MD

  • APHP Hôpital Européen Georges Pompidou

    Paris, 75015

    Antoine MARIANI, MD, +33156093562, antoine.mariani@aphp.fr

    Antoine MARIANI, MD

  • Hospices Civils de Lyon - Hôpital Lyon Sud

    Pierre-Bénite, 69495

    Vahan KEPENEKIAN, MD, +33478862371, vahan.kepenekian@chu-lyon.fr

    Vahan KEPENEKIAN, MD

  • Institut de Cancérologie de l'Ouest - Saint Herblain

    Saint-Herblain, 44805

    Frédéric DUMONT, MD, +33240679900, frédéric.dumont@ico.unicancer.fr

    Frédéric DUMONT, MD

  • Hôpital d'Instruction des Armées Bégin

    Saint-Mandé, 94160

    Anne-Cécile EZANNO, MD, +33143985250, ezanno.annececile@gmail.com

    Anne-Cécile EZANNO, MD

  • CHRU

    Strasbourg, 67098

    Cécile BRIGAND, MD, +33388126085, cecile.brigand@chru-strasbourg.fr

    Cécile BRIGAND, MD

  • Centre Hospitalier TARBES

    Tarbes, 65013

    Amandine PINTO, Doctor, apinto@ch-tarbes-vic.fr

    +33562546231

  • Institut de Cancérologie de Lorraine (ICL)

    Vandœuvre-lès-Nancy, 54500

    Cécilia CERIBELLI, MD, +33383598451, c.cerribelli@nancy.unicancer.fr

    Cécilia CERIBELLI, MD

  • Gustave Roussy

    Villejuif, 94805

    Isabelle SOURROUILLE, MD, +33142114350, isabelle.sourrouille@gustaveroussy.fr

    Isabelle SOURROUILLE, MD

Other trials in France

About this study

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

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.

Read more

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
Being tested
Standard Medical Therapy, PIPAC
Keywords
Surgical oncology, Peritoneal metastasis, Pressurized IntraPeritoneal Aerosol Chemotherapy, Systemic chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Medical TherapyDrug

    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.

  • PIPACProcedure or surgery

    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.

Study groups in NCT06681038
Study groupRoleWhat they receive
Control ARMActive comparatorSystemic treatments
Receives: Drug: Standard Medical Therapy
Experimental ARMExperimentalPIPAC procedure with pressurized aerosol containing oxaliplatin.
Receives: Drug: Standard Medical Therapy; Procedure: PIPAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From randomisation to 18 months after last patient randomisation

Secondary outcomes (6)

  1. Overall survival (OS) between the two groups

    Overall survival (OS) defined as the time between randomisation and death from any cause

    Measured: From randomisation to 18 months after last patient randomisation

  2. EORTC QLQ-C30 questionnaire

    Quality of life between the two groups evaluated by the score of EORTC QLQ-C30 questionnaire

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

  3. EORTC QLQ-CR29 questionnaire

    Quality of life between the two groups evaluated by the scores of EORTC QLQ-CR29 questionnaire

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

  4. Peritoneal progression free survival (PPFS) between the two groups

    Peritoneal progression free survival defined as the time between the date of randomisation and the date of peritoneal progression or death from any cause.

    Measured: From randomisation to 18 months after last patient randomisation

  5. Obstruction-free survival (OFS) between the two groups

    Obstruction-free survival is defined as the time between the date of randomisation and the appearance of gastrointestinal obstruction requiring medication with high dose of corticosteroïd (> 1mg/kg) or intervention as nasogastric decompression, intraluminal stenting, surgical bypass, or decompression stomy (gastrostomy or ileo/colostomy) or death.

    Measured: From randomisation to 18 months after last patient randomisation

  6. Histological tumor response

    Peritoneal regression grading score (PRGS) on biopsies performed at surgical exploration in both groups, and systematically during 1st and 2nd PIPAC procedure.

    Measured: At the end of the 12th course of treatment (week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study startFeb 2025 (estimated)
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06681038
Sponsor's protocol ID
ICO-2023-14
Acronym
PIPOX02
Status last verified
Nov 2024
First submitted
5 Nov 2024
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Standard Medical Therapy and PIPAC in people with Peritoneal Metastases from Colorectal Cancer, run by Institut Cancerologie de l'Ouest at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frédéric DUMONT, MD (+33240679900, frederic.dumont@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) between the two groups (time frame: From randomisation to 18 months after last patient randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06681038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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