Treatment for colorectal cancer with hyperthermic chemotherapy
EFFIPEC - Efficacy of Hyperthermic Intraperitoneal Chemotherapy, Single-arm Phase I Study, Followed by an Open-label, Randomized, Controlled Registry-based Phase III Trial
This study is testing if a new combination of chemotherapy drugs given after surgery can help people with colorectal cancer that has spread to the lining of the abdomen feel better and live longer compared to standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 213 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Ahmedabad and 4 other locations) |
| Trial ID | NCT04861558 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 78 with colorectal cancer and peritoneal metastases who are eligible for cytoreductive surgery.
Not a fit: Patients with severe allergic reactions to the chemotherapy agents or those with metastases beyond the peritoneum, liver, or lung may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced colorectal cancer.
How similar studies have performed: Previous studies have shown promising results with HIPEC in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ahmedabad and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.