Tests heated chemotherapy during surgery for colorectal cancer spread in the abdomen
Tests heated chemotherapy given during surgery in adults with colorectal cancer in the abdomen.
Plain-language title generated from the registry record
Registry title: Efficacy of Hyperthermic Intraperitoneal Chemotherapy
Key facts
- Where
- Goteborg, Malmo, Solna, and Uppsala, SwedenSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal cancer that has spread to the lining of the abdomen (peritoneum), who are planned for surgery with heated chemotherapy washed through the abdomen (HIPEC).
- Age
- 18 to 78 years old
- Sex
- All sexes can join.
- Disease stage
- Colorectal cancer with peritoneal metastases, with or without liver metastases (maximum 3). Lung metastases that can be removed by surgery are allowed.
- Earlier treatment
- No previous cytoreductive surgery (CRS) or HIPEC. No severe toxicity or allergic reaction to oxaliplatin, irinotecan or 5-fluorouracil. No other cancer therapy within 4 weeks before the study treatment.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Metastases other than in the peritoneum, liver or lung
- Active infection needing antibiotics
- Active hepatitis B or C, or known HIV
- Cancer that did not start in the colon or rectum
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 79 years old?
Source: NCT04861558, who can take part
Where in Sweden
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborg, SwedenTaking people
- Region Skane Skanes UniversitetssjukhusMalmo, SwedenTaking people
- Karolinska University HospitalSolna, SwedenTaking people
- Uppsala University HospitalUppsala, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Uppsala University
- Trial code
- NCT04861558EU 2024-516224-34-00
- Record updated
- 30 May 2025
- Original description
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.Read full original descriptionShow less
EFFIPEC - Efficacy of Hyperthermic Intraperitoneal Chemotherapy, Single-arm Phase I Study, Followed by an Open-label, Randomized, Controlled Registry-based Phase III Trial
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 following group of patients.
To study efficacy, randomization is performed intraoperatively. The patient is followed up postoperatively for a total of 3 years for the secondary endpoints which may be extended by the study committee to 5 years. Since the trial is registry based, the long-term follow-up does not require separate eCRF evaluations. These evaluations can be automatically retrieved from the registry - both recurrence data, quality of life, and morbidity data. Some specific eCRF evaluations will be integrated as a separate study part of the HIPEC registry, such as inclusion/exclusion criteria and adverse event reporting (including SUSAR reporting).
Inclusion: 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; ≥ 18 years old and ≤78 years old; Colorectal cancer with peritoneal metastases +/- liver metastases (maximum 3); Concomitant resectable pulmonary metastases are allowed; 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: Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil; Complex liver-perenchymal sparing surgery or hemihepatectomy procedures are to be excluded; Previous CRS or HIPEC; Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment; Active infections requiring antibiotics; Active liver disease with positive serology for active hepatitis B, C, or known HIV; Histopathology of other origin than colorectal cancer; Unable to tolerate intensified HIPEC treatment due to comorbidity; Metastasis other than peritoneum or liver or lung; Pregnant or lactating (nursing) women; Incomplete cytoreduction defined as completeness of cytoreduction score 2-3.