Pressurized Chemotherapy for High Risk Colon Cancer Patients
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial
This study is testing a new type of chemotherapy for patients with high-risk colon cancer to see if it can help prevent cancer from coming back after surgery and standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Odense) |
| Trial ID | NCT03280511 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are radically resected colon cancer patients with high-risk tumors, specifically those with perforated or advanced stage cancers.
Not a fit: Patients with proven relapse or those who have had prior cytoreductive surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence in high-risk colon cancer patients.
How similar studies have performed: While PIPAC is a relatively novel approach, other studies have shown promising results in treating peritoneal metastases with similar methodologies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Odense
- Odense PIPAC Center, Department of Surgery, Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Martin Graversen, MD — Odense PIPAC Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.