Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

PIPAC

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

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)

Location Location Status
Denmark
Odense PIPAC Center, Department of Surgery, Odense University Hospital
Odense 5000
Recruiting

Inclusion Criteria

Inclusion Criteria:

Radically resected colon cancer patients with adeno- or signet ring cell carcinomas with high-risk tumors defined as: perforated / pT4NanyM0 (UICC 8th edition) / pTanyNanyM1 with radically resected PM including ovarian metastases
Performance status 0-1
Fertile women must use approved contraceptives (see below)
Age > 18 years
Written informed consent

Exclusion Criteria

Exclusion Criteria:

Radiologically or clinically proven relapse.
Previous cytoreductive surgery (CRS) with HIPEC
Other malignant diagnosis within the last 2 years
Contraindications to laparoscopy (e.g. severe adhesions, peritonitis)
A history of allergic reaction to oxaliplatin or other platinum containing compounds
Renal impairment, defined as GFR 2.
Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
Inadequate haematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.

NCT ID

NCT03280511

Date Trial Added

2017-09-12

Updated Date

2022-10-06