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NCT06681038Not yet recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
114 (estimated)
First submitted
5 Nov 2024
Start date
Feb 2025
Primary completion date
Aug 2029
Lead sponsor
Institut Cancerologie de l'Ouest
NCT number
NCT06681038

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 114
  • From Feb 2025 to the primary completion date, Aug 2029
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 6 months prior to enrolment;

Other illness

  • 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);
  • Extraperitoneal polymetastatic diseases. (Only oligometastatic1 diseases are allowed for inclusion);
  • Active gastrointestinal bleeding;
  • Inflammatory bowel disease;

Other

  • Mutational status corresponding to microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR);
  • Complete or partial bowel obstruction unresponsive to medical treatment;
  • Peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0, grade ≥2

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre François Baclesse
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CaenFranceUnknown status
Centre Georges François Leclerc
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DijonFranceUnknown status
CHU
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LilleFranceUnknown status
Chu Dupuytren
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LimogesFranceUnknown status
Aphm La Timone
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MarseilleFranceUnknown status
Institut de Cancérologie de Montpellier (ICM)
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
APHP Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
APHP Saint Louis
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ParisFranceUnknown status
Hospices Civils de Lyon - Hôpital Lyon Sud
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Pierre-BéniteFranceUnknown status
Institut de Cancérologie de l'Ouest - Saint Herblain
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Saint-HerblainFranceUnknown status
Hôpital d'Instruction des Armées Bégin
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Saint-MandéFranceUnknown status
CHRU
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StrasbourgFranceUnknown status
Centre Hospitalier TARBES
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TarbesFranceUnknown status
Institut de Cancérologie de Lorraine (ICL)
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Vandœuvre-lès-NancyFranceUnknown status
Gustave Roussy
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VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.