NCT04861558RecruitingPhase 3
Efficacy of Hyperthermic Intraperitoneal Chemotherapy
EFFIPEC - Efficacy of Hyperthermic Intraperitoneal Chemotherapy, Single-arm Phase I Study, Followed by an Open-label, Randomized, Controlled Registry-based Phase III Trial
Source: ClinicalTrials.gov · Last updated 30 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 213 (estimated)
- First submitted
- 6 Apr 2021
- Start date
- 1 May 2021
- Primary completion date
- Dec 2025
- Lead sponsor
- Uppsala University
- Diseases
- Colorectal cancer
- NCT number
- NCT04861558
- EU CT number
- 2024-516224-34-00
- EudraCT number
- 2020-005210-18
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 213
- From 1 May 2021 to the primary completion date, Dec 2025
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| INDEPSO Coordinator of this site? Confirm its status | Ahmedabad | India | Recruiting |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.