Status:
RECRUITING
Efficacy of Hyperthermic Intraperitoneal Chemotherapy
Lead Sponsor:
Uppsala University
Conditions:
Colorectal Cancer
Peritoneal Metastases
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
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 mo...
Detailed Description
Not detailed description entered.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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 criteria:
- Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil
- Unable to tolerate intensified HIPEC treatment due to comorbidity
- Metastasis other than peritoneum or liver or lung
- Complex liver-perenchymal sparing surgery or hemihepatectomy procedures are to be excluded.
- Previous CRS or HIPEC
- Pregnant or lactating (nursing) women
- Active infections requiring antibiotics
- Active liver disease with positive serology for active hepatitis B, C, or known HIV
- Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment
- Incomplete cytoreduction defined as completeness of cytoreduction score 2-3
- Histopathology of other origin than colorectal cancer
Exclusion
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT04861558
Start Date
May 1 2021
End Date
December 1 2029
Last Update
May 30 2025
Active Locations (5)
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1
INDEPSO
Ahmedabad, India
2
Sahlgrenska östra sjukhuset
Gothenburg, Sweden
3
Skånes universitetssjukhus
Malmo, Sweden
4
Karolinska sjukhuset
Stockholm, Sweden