Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial
Who is this study for? Adult patients with Colon Cancer
What treatments are being studied? Pressurized Intraperitoneal Aerosol Chemotherapy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Odense PIPAC Center, Department of Surgery, Odense University Hospital
RECRUITING
Odense
Time Frame
Start Date: 2017-12-14
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 60
Treatments
Experimental: Interventional
Eligible candidates will be enrolled according to in-/exclusion criteria. Two months after colon resection or immediately after adjuvant chemotherapy (if indicated), a standard laparoscopy including peritoneal lavage, peritoneal biopsies and PIPAC treatment with oxaliplatin 92 mg/m2 will be planned. This procedure will be repeated after another 5 weeks. Follow up CTs after 12, 24 and 36 months will be planned.
Related Therapeutic Areas
Sponsors
Leads: Michael Bau Mortensen