Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMichael Bau Mortensen
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- PIPAC
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Michael Bau Mortensen
Lead sponsor
Odense University Hospital
Sponsor institution
Source ClinicalTrials.gov