Pressurized Chemotherapy for High Risk Colon Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study offers two treatments of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with oxaliplatin to patients who have undergone primary resection for high-risk colon cancer. It aims to investigate the presence of free intraperitoneal tumor cells after surgery and standard chemotherapy. The study targets patients with a significant risk of peritoneal metastases, which is a common site of cancer recurrence. By using PIPAC, the researchers hope to improve outcomes for patients who are typically faced with limited treatment options.

Why it matters

Who can join: the full rules

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.

Where it's running

• Odense PIPAC Center, Department of Surgery, Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Principal investigator: Martin Graversen, MD — Odense PIPAC Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Liquid biopsy and machine learning to detect early colorectal cancer, advanced adenomas, Lynch-related cancers, and residual disease

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.