Efficacy of Hyperthermic Intraperitoneal Chemotherapy

A dose titration study and a combined superiority registry-based open-label randomized control trial is planned to answer the trial objectives. The study will be registry-based to allow simpler and more comprehensive follow-up. Patients with colorectal cancer will be treated with cytoreductive surgery (CRS) together with either standard oxaliplatin HIPEC (the control for the efficacy study) or oxaliplatin/irinotecan HIPEC in combination with 5-FU 24-hour EPIC. The 5-FU will be administered postoperatively when the abdomen is completely sutured. The drug is divided equally into 2 injections of

Trial Details

NCT ID
NCT04861558
Phase
PHASE3
Sponsor
Uppsala University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • 5Fluorouracil
  • Irinotecan
  • Oxaliplatin
Locations (sample)
  • Ahmedabad, India|23.02579,72.58727
  • Gothenburg, Sweden|57.70716,11.96679
  • Malmö, Sweden|55.60587,13.00073
  • Stockholm, Sweden|59.32938,18.06871
  • Uppsala, Sweden|59.85882,17.63889

Key Eligibility Criteria

  • Provision of written informed consent prior to any study specific procedures.
  • ECOG Performance Status Score 0,1 or 2 alternatively Karnofsky 60-100
  • Adequate kidney, liver, bone marrow function according to laboratory tests
  • For females of childbearing potential, a negative pregnancy test must be documented

For full eligibility, visit ClinicalTrials.gov.

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