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

Launched by MICHAEL BAU MORTENSEN · Sep 9, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) using a drug called oxaliplatin for patients who have had surgery for high-risk colon cancer. The goal is to see if giving this treatment after surgery and standard chemotherapy can help find and eliminate any remaining cancer cells in the abdomen, which is an important aspect of preventing cancer from coming back. The trial is currently recruiting participants aged 18 and older who have undergone successful surgery for specific types of high-risk colon cancer.

To be eligible for this trial, patients must have had their colon cancer surgically removed and have certain high-risk features in their diagnosis. They should be in good overall health, meaning they can perform daily activities without much difficulty. Participants will receive two PIPAC treatments and will be closely monitored throughout the study. It’s important to note that this trial is not for everyone, as there are some medical conditions and previous treatments that could exclude a patient from participating. If you or a loved one is interested, discussing this trial with a doctor can help determine if it’s a suitable option.

Gender

ALL

Eligibility 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:
• • 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.