RecruitingPhase 2NCT03280511

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

Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial


Sponsor

Michael Bau Mortensen

Enrollment

60 participants

Start Date

Dec 14, 2017

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new technique called PIPAC (Pressurized IntraPeritoneal Aerosol Chemotherapy) — where chemotherapy is sprayed as a fine mist into the abdominal cavity through a minimally invasive procedure — as a preventive treatment after surgery in colon cancer patients at high risk of the cancer returning in the belly lining. **You may be eligible if...** - You have had surgery to fully remove your colon cancer, and your tumor was high-risk: either it perforated (ruptured) or invaded through the bowel wall (T4) or had limited spread to the lining of the abdomen or ovaries (which was also removed) - You are in good overall health (performance status 0–1) and over 18 - You have adequate kidney, liver, and blood function **You may NOT be eligible if...** - Imaging or clinical exams show the cancer has come back - You have previously had a type of heated abdominal chemotherapy wash surgery (HIPEC) - You have had another cancer diagnosis within the last 2 years - You have an allergy to oxaliplatin (platinum-based chemotherapy) - You have poor kidney, heart, or liver function - You have conditions that make laparoscopy (minimally invasive surgery) unsafe, like severe abdominal scarring Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPIPAC

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


Locations(1)

Odense PIPAC Center, Department of Surgery, Odense University Hospital

Odense, Denmark

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NCT03280511


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