Treatment for colorectal cancer with hyperthermic chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) combined with cytoreductive surgery in patients with colorectal cancer and peritoneal metastases. Participants will be randomized to receive either standard oxaliplatin HIPEC or a combination of oxaliplatin, irinotecan, and 5-fluorouracil administered postoperatively. The study includes a dose titration component to optimize the 5-FU dosage based on patient response. Follow-up will be registry-based to ensure comprehensive data collection and monitoring.

Why it matters

Who can join: the full rules

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

Where it's running

• Indepso
  Ahmedabad, India Recruiting
• Sahlgrenska östra sjukhuset
  Gothenburg, Sweden Recruiting
• Skånes universitetssjukhus
  Malmö, Sweden Recruiting
• Karolinska sjukhuset
  Stockholm, Sweden Recruiting
• Akademiska sjukhuset
  Uppsala, Sweden Recruiting

Study contacts

• Principal investigator: Peter Cashin, MD, PhD — Uppsala University Hospital
• Study coordinator: Peter Cashin, MD, PhD
• Email: peter.cashin@surgsci.uu.se
• Phone: +46 (0)18 6174304

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.