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Systemic antitumor treatment with or without pressurized intraperitoneal aerosol chemotherapy (PIPAC) for colon peritoneal metastases – a multicentre phase II randomized trial (PIPOX02)
EU CTIS ID: 2024-514560-10-00
What this study is testing
Evaluate an improvement in progression free survival (PFS) between the group combining systemic treatments (chemotherapy + targeted therapy) and PIPAC and the group with systemic treatment alone in patients with peritoneal metastases in advanced colon cancer (PCI>15).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Age ≥ 18 years;
- 11) Men and women* must use effective contraceptive measures during the treatment and for at least 15 months after the last dose received; (* of childbearing age);
- 10) Creatinine clearance ≥ 30 mL/min
- 12) No known risk of irinotecan toxicity
- 13) No Dihydropyrimidine dehydrogenase deficit (uracil blood Level <16ng/ml);
- 14) Patient is willing and able to comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations, including follow up;
You likely can't join if
- 1) Other cancer treated within the last 3 years, with the exception of in situ cervical carcinoma or basocellular carcinoma;
- 9) Clinically relevant and uncontrolled coronary heart disease, myocardial infarction within the past 12 months;
- 19) Known history of hypersensibility to fluorouracil, folinic acid, irinotecan, oxaliplatin, capecitabine, cetuximab, panitumumab, bevacizumab or to any of their excipients, according to the SmPCs of these products.
- 10) Uncontrolled arrhythmia;
- 20) Concomitant treatment with brivudine, sorivudine or their chemically related analogues (according to the SmPC of fluorouracile)
- 21) Live attenuated vaccines and for 6 months following cessation of chemotherapy (according to the SmPCs of fluorouracile and irinotecan);
See the full eligibility criteria
Who can join
- 1) Age ≥ 18 years;
- 11) Men and women* must use effective contraceptive measures during the treatment and for at least 15 months after the last dose received; (* of childbearing age);
- 10) Creatinine clearance ≥ 30 mL/min
- 12) No known risk of irinotecan toxicity
- 13) No Dihydropyrimidine dehydrogenase deficit (uracil blood Level <16ng/ml);
- 14) Patient is willing and able to comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations, including follow up;
- 15) Patient has valid health insurance.
- 2) Written informed consent obtained from the patient before any study procedure;
- 3) ECOG performance status of 0 to 2;
- 4) Histopathologically confirmed colonic adenocarcinoma with synchronous or metachronous peritoneal metastasis (PM);
- 5) 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.
- 6) A surgical exploration performed less than 4 weeks before inclusion (if not, a laparoscopic exploration must be performed);
- 7) Indication of 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;
- 8) No extended intraperitoneal adherences confirmed by surgical exploration (laparoscopy or laparotomy) in at least 9 out of 13 abdominal regions;
- 9) Neutrophils count ≥ 1.5 x 109/L, platelet count ≥ 100 x109/L, hemoglobin ≥ 9 g/dL; Total bilirubin < 1.5 x ULN (upper limit of normal), ASAT and ALAT <3 x ULN, Alkaline phosphatase <1.5 x ULN, Serum creatinine < 1.5 x ULN;
What rules you out
- 1) Other cancer treated within the last 3 years, with the exception of in situ cervical carcinoma or basocellular carcinoma;
- 9) Clinically relevant and uncontrolled coronary heart disease, myocardial infarction within the past 12 months;
- 19) Known history of hypersensibility to fluorouracil, folinic acid, irinotecan, oxaliplatin, capecitabine, cetuximab, panitumumab, bevacizumab or to any of their excipients, according to the SmPCs of these products.
- 10) Uncontrolled arrhythmia;
- 20) Concomitant treatment with brivudine, sorivudine or their chemically related analogues (according to the SmPC of fluorouracile)
- 21) Live attenuated vaccines and for 6 months following cessation of chemotherapy (according to the SmPCs of fluorouracile and irinotecan);
- 22) Concomitant use with St John's Wort (according to the SmPC of irinotecan);
- 23) Severe renal insufficiency (creatinine clearance < 30 mL/min, according to the SmPC of capecitabine;
- 24) History of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose) (according to the SmPC of cetuximab);
- 25) Interstitial lung disease (according to the SmPCs of cetuximab and panitumumab);
- 26) Pulmonary fibrosis (according to the SmPC of panitumumab);
- 18) QT/QTc interval longer than 450 msec for men and longer than 470 msec for women on the inclusion ECG
- 27) Hypersensitivity to Chinese hamster ovary (CHO) cell products (according to the SmPC of bevacizumab)
- 28) Pregnancy or breast-feeding period;
- 29) Medical, geographical, sociological, psychological or legal conditions that would not permit the patient completing the study or signing the informed consent form.
- 11) Uncontrolled hypertension;
- 12) Inflammatory bowel disease;
- 13) Ongoing non-healing wounds, ulcers or bone fractures;
- 14) Relevant proteinuria (nephrotic syndrome); arterial thromboembolisms or severe haemorrhages within 6 months before study enrolment (except a bleeding tumour before tumour resection surgery) precluding the use of anti-VEGF drug;
- 15) Haemorrhagic diathesis or thrombotic tendency;
- 16) Peripheral neuropathy oxaliplatin-related according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0;
- 17) No reversible electrolyte disorders such as hypokalemia, hypocalcemia or hypomagnesemia.
- 2) Rectal cancer primary (tumor <15 cm from the anal verge);
- 30) Appendix cancer
- 3) Mutational status corresponding to microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR)
- 4) Complete or partial bowel obstruction unresponsive to medical treatment;
- 5) Extraperitoneal polymetastatic diseases. (Only oligometastatic1 diseases are allowed for inclusion) 1. 1oligo-metastatic disease as defined up to 3 liver metastases less than 5 cm in diameter and/or up to 3 lung nodules less than 10 mm in diameter and/or ovarian metastasis of any size.
- 6) History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 6 months prior to enrolment;
- 7) Active gastrointestinal bleeding;
- 8) Severe ongoing infection;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.