NCT03280511 Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
| NCT ID | NCT03280511 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Michael Bau Mortensen |
| Condition | Peritoneum Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2017-12-14 |
| Primary Completion | 2024-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2017-12-14 with a primary completion date of 2024-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Martin Graversen, MD
PRINCIPAL INVESTIGATOR
Odense PIPAC Center
Frequently Asked Questions
Who can join the NCT03280511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peritoneum Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03280511 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03280511 currently recruiting?
Yes, NCT03280511 is actively recruiting participants. Visit ClinicalTrials.gov or contact Michael Bau Mortensen to inquire about joining.
Where is the NCT03280511 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT03280511 clinical trial?
NCT03280511 is sponsored by Michael Bau Mortensen. The principal investigator is Martin Graversen, MD at Odense PIPAC Center. The trial plans to enroll 60 participants.
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