AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Efficacy of Hyperthermic Intraperitoneal Chemotherapy

RecruitingPhase 3Ages 18 Years - 79 YearsAllUppsala University
💬

In plain words

What the trial is, and whether it could suit you

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 200 ml each and injected through two abdominal drains that are clamped for 16 hours. For dose escalation, the titration groups (á 3 or 6 patients) are followed for 30 days postoperatively after which the Data Monitoring Committee (DMC) will determine whether or not to increase the 5-FU dose for the

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion criteria: 1. Provision of written informed consent prior to any study specific procedures. 2. ECOG Performance Status Score 0,1 or 2 alternatively Karnofsky 60-100 3. Adequate kidney, liver, bone marrow function according to laboratory tests 4. For females of childbearing potential, a negative pregnancy test must be documented 5. ≥ 18 years old and ≤78 years old 6. Colorectal cancer with peritoneal metastases +/- liver metastases (maximum 3) 7. Concomitant resectable pulmonary metastases are allowed 8. All patients deemed eligible for CRS and HIPEC according to clinical routine management during a HIPEC multidisciplinary board at each respective hospital can be included. Exclusion criteria: 1. Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil 2. Unable to tolerate intensified HIPEC treatment due to comorbidity 3. Metastasis other than peritoneum or liver or lung 4. Complex liver-perenchymal sparing surgery or hemihepatectomy procedures are to be excluded. 5. Previous CRS or HIPEC 6. Pregnant or lactating (nursing) women 7. Active infections requiring antibiotics 8. Active liver disease with positive serology for active hepatitis B, C, or known HIV 9. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment 10. Incomplete cytoreduction defined as completeness of cytoreduction score 2-3 11. Histopathology of other origin than colorectal cancer
💊

What it tests

  • 5Fluorouracil
  • Irinotecan
  • Oxaliplatin
📍

Where

5 sites
INDEPSO
Ahmedabad, India
Sahlgrenska östra sjukhuset
Gothenburg, Sweden
Skånes universitetssjukhus
Malmö, Sweden
Karolinska sjukhuset
Stockholm, Sweden
Akademiska sjukhuset
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy