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
- Diseases
- Colorectal cancer
- 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
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Chu Dupuytren Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Aphm La Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Institut de Cancérologie de Montpellier (ICM) Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| APHP Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| APHP Saint Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hospices Civils de Lyon - Hôpital Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Institut de Cancérologie de l'Ouest - Saint Herblain Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Hôpital d'Instruction des Armées Bégin Coordinator of this site? Confirm its status | Saint-Mandé | France | Unknown status |
| CHRU Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Centre Hospitalier TARBES Coordinator of this site? Confirm its status | Tarbes | France | Unknown status |
| Institut de Cancérologie de Lorraine (ICL) Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.