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
- Ahmedabad, IndiaSee the site
- Phase
- Phase 3
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 India
- INDEPSOAhmedabad, IndiaTaking 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.