Actively Recruiting
EFFIPEC - Efficacy of Hyperthermic Intraperitoneal Chemotherapy Comparing Standard Oxaliplatin HIPEC to Intensified Oxaliplatin/Irinotecan HIPEC with Postoperative 5-Fluorouracil in Colorectal Cancer with Peritoneal Metastases
Led by Uppsala University · Updated on 2025-05-30
213
Participants Needed
5
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with colorectal cancer who have peritoneal metastases, with or without limited liver metastases. This study combines a dose titration phase and an open-label randomized control trial using registry-based follow-up to compare the effectiveness of two types of hyperthermic intraperitoneal chemotherapy (HIPEC). The study aims to understand if adding irinotecan and 5-fluorouracil (5-FU) to the standard oxaliplatin HIPEC improves outcomes. Follow-up will assess recurrence, survival, complications, and quality of life up to five years. Participants will undergo cytoreductive surgery (CRS) followed by either the standard HIPEC with oxaliplatin and intravenous 5-fluorouracil during surgery, or an intensified HIPEC combining oxaliplatin, irinotecan, and a 24-hour postoperative infusion of 5-FU through abdominal drains. The 5-FU dose will be given in two equal injections through drains clamped for 16 hours. The dose escalation part monitors small groups of patients for 30 days before adjusting doses, while the randomized phase assigns patients intraoperatively to either treatment. The long-term follow-up uses registry data to track outcomes without extra study visits. During the study, patients will be monitored for recurrence-free survival at 24 months, overall survival and recurrence at 5 years, postoperative complications within 30 days, and quality of life over 3 years. Specific evaluations, adverse event reporting, and eligibility data are collected within the HIPEC registry. The trial includes standard laboratory tests and clinical assessments to ensure safety and treatment tolerability. Participants will be followed through routine care and registry records for up to five years after treatment.
CONDITIONS
Brief Title
Efficacy of Hyperthermic Intraperitoneal Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent provided before any study procedures
- ECOG Performance Status 0, 1, or 2, or Karnofsky score 60-100
- Adequate kidney, liver, and bone marrow function by lab tests
- Negative pregnancy test for women of childbearing potential
- Age between 18 and 78 years
- Diagnosis of colorectal cancer with peritoneal metastases, with or without up to 3 liver metastases
- Resectable pulmonary metastases allowed
- Eligibility for cytoreductive surgery and HIPEC confirmed by multidisciplinary board
You will not qualify if you...
- Previous severe allergic reactions or toxicity to oxaliplatin, irinotecan, or 5-fluorouracil
- Unable to tolerate intensified HIPEC due to other health conditions
- Metastases outside peritoneum, liver, or lung
- Complex liver surgery such as hemihepatectomy planned
- Prior cytoreductive surgery or HIPEC treatment
- Pregnant or breastfeeding women
- Active infections requiring antibiotics
- Active liver disease with hepatitis B, C, or HIV
- Other cancer treatments within 4 weeks before or after study treatment
- Incomplete cytoreduction with score 2 or 3
- Cancer histology other than colorectal origin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with either standard or intensified drug regimens, including intraoperative and postoperative drug injections.
1 hospitalization period including surgery and immediate post-operative monitoring
Duration - Approximately 4 to 5 days post-surgery
Participants receive postoperative chemotherapy with 5-fluorouracil administered through abdominal drains as part of the intensified treatment arm.
Daily administration during hospital stay
Duration - Up to 5 years after treatment
Participants are monitored for recurrence-free and overall survival, postoperative complications, and quality of life over several years after treatment.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 5 locations
1
INDEPSO
Ahmedabad, India
Actively Recruiting
2
Sahlgrenska östra sjukhuset
Gothenburg, Sweden
Actively Recruiting
3
Skånes universitetssjukhus
Malmö, Sweden
Actively Recruiting
4
Karolinska sjukhuset
Stockholm, Sweden
Actively Recruiting
5
Akademiska sjukhuset
Uppsala, Sweden, 75185
Actively Recruiting
Research Team
P
Peter Cashin, MD, PhD
L
Lana Ghanipour, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here