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Recruiting Phase 2

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

NCT03280511 · tracked via the Priya Life Science Denmark tracker
Sponsor
Michael Bau Mortensen
Phase
Phase 2
Started
2017-12-14
Last updated
2022-10-06

Condition(s) studied

Peritoneum CancerPeritoneal CarcinomatosisPeritoneal MetastasesColo-rectal Cancer

Investigational drug(s) / intervention(s)

PIPAC →

PIPAC: PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg. During PIPAC, oxaliplatin 46 mg/m2 in 150 ml dextrose will be intraperitoneally nebulized at a rate of 0.5 ml/s with a maximum pressure of 200 PSI. The intraperitoneal air will be evacuated after 30 minutes of simple diffusion

Study summary

In this study, patients will be offered two Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) treatments with oxaliplatin after primary resection and standard adjuvant chemotherapy (if indicated) for colon cancer. Furthermore, the study will explore, whether it is possible to find free intraperitoneal tumor cells (FITC) after resection and adjuvant chemotherapy for colon cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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: * 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 \< 50 ml/min, (Cockcroft-Gault Equation). * Myocardial insufficiency, defined as NYHA class \> 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.

Primary outcome measure(s)

  • The number of patients with peritoneal recurrence — 3 years
    Based on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer.

Trial sites (1)

FacilityCityRegionStatus
Odense PIPAC Center, Department of Surgery, Odense University Hospital Odense Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03280511 on ClinicalTrials.gov ↗ ← All trials in Denmark