NCT04861558 Efficacy of Hyperthermic Intraperitoneal Chemotherapy
| NCT ID | NCT04861558 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Uppsala University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 213 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 213 participants in total. It began in 2021-05-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Contact & Investigator
Peter Cashin, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT04861558 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04861558 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 213 participants.
Is NCT04861558 currently recruiting?
Yes, NCT04861558 is actively recruiting participants. Contact the research team at peter.cashin@surgsci.uu.se for enrollment information.
Where is the NCT04861558 trial being conducted?
This trial is being conducted at Ahmedabad, India, Gothenburg, Sweden, Malmö, Sweden, Stockholm, Sweden and 1 additional location.
Who is sponsoring the NCT04861558 clinical trial?
NCT04861558 is sponsored by Uppsala University. The principal investigator is Peter Cashin, MD, PhD at Uppsala University Hospital. The trial plans to enroll 213 participants.
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