RecruitingRecruiting
Efficacy of Hyperthermic Intraperitoneal Chemotherapy
NCT04861558 · Uppsala University
In plain English
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Official title
EFFIPEC - Efficacy of Hyperthermic Intraperitoneal Chemotherapy, Single-arm Phase I Study, Followed by an Open-label, Randomized, Controlled Registry-based Phase III Trial
About this study
Not detailed description entered.
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
Study design
Enrollment target: 213 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-05-01
Estimated completion: 2029-12
Last updated: 2025-05-30
Interventions
Drug: 5FluorouracilDrug: IrinotecanDrug: Oxaliplatin
Primary outcomes
- • Recurrence-free survival (24 months after treatment)
Sponsor
Uppsala University · other
Contacts & investigators
ContactPeter Cashin, MD, PhD · contact · peter.cashin@surgsci.uu.se · +46 (0)18 6174304
ContactLana Ghanipour, MD, PhD · contact · lana.ghanipour@surgsci.uu.se · +46 (0)18 6110000
InvestigatorPeter Cashin, MD, PhD · principal_investigator, Uppsala University Hospital
All locations (5)
INDEPSORecruiting
Ahmedabad, India
Sahlgrenska östra sjukhusetRecruiting
Gothenburg, Sweden
Skånes universitetssjukhusRecruiting
Malmö, Sweden
Karolinska sjukhusetRecruiting
Stockholm, Sweden
Akademiska sjukhusetRecruiting
Uppsala, Sweden