Program Status
RecruitingPhase
Phase 1Prior Immunotherapy Allowed
YesCRC-directed Trial
YesTags
MSI-H/ MMRd, MSS/ MMRpComments
PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) is a local treatment for peritoneal metastases.
-A new system of drug delivery, to the interior of the peritoneum.
-Chemotherapy gets delivered (as aerosol, under pressure) directly, where the lesions inside the peritoneum are.
-Palliative; it would allow some patients to pursue, later or at the same time, other treatments/ treat other problematic areas (lung, liver) with other therapies.
-Available at several European locations, mainly, in Germany, outside clinical trial.
-It’s minimally invasive (laparoscopic access to the peritoneum).
-Low systemic toxicity.
-Can be administered concomitantly with systemic chemotherapy.
-Feasible is cases where CRS/HIPEC is not possible.
Main criteria for PIPAC are:
– peritoneal metastasis no suitable for CRS-HIPEC
– no small bowel obstruction, ability to eat, no gastric tubing, no parenteral feeding.
– ECOG 1 or 2 (Karnofsky 60% or more)
(Read Description and Inclusion/ Exclusion criteria)
Location | Location Status |
---|---|
United Kingdom | |
Imperial College Healthcare NHS Trust London W2 1NY |
Recruiting |
Contacts
Inclusion Criteria
Inclusion Criteria:
Patients with CPM with expected life expectancy of > 6 months.
ECOG Scale of Performance Status (PS) scores 0 or 1.
15 mile catchment area to facilitate overseeing systemic chemotherapy administration
Concomitant systemic chemotherapy regimens with FOLFIRI, FOLFOX, Mitomycin C & Fluorouracil, Capecitabine (excluding Lonsurf) or without systemic chemotherapy if no systemic options available to patient
Neutrophil count on or just before chemotherapy due date of >1.5
Exclusion Criteria
Exclusion Criteria:
Age <18
MDT decision that patient not suitable for PIPAC
Decision by Preoperative Assessment Department or Consultant Anaesthetist that patient not fit for general anaesthesia and / or laparoscopy
Clinically evident gross ascites
Bowel obstruction
Bevacizumab as part of systemic chemotherapy regime - time from chemotherapy to surgery would be too long for PIPAC to be feasible
Previous bone marrow suppression due to chemotherapy given risk of post-operative neutropenia