Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
213
Countries
1
Sites
4
Colorectal cancer
Phase I: To determine the maximum tolerated dose of 5-Fluorouracil 24-hour EPIC, in combination with intensified oxaliplatin/irinotecan HIPEC, for treatment of colorectal cancer. Phase III: To study the recurrence-free survival (RFS) of patients within 24 months
Key facts
- Sponsor
- Uppsala University
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Aug 2024 → ongoing
- Decision date (initial)
- 2024-08-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Swedish Research Council
External identifiers
- EU CT number
- 2024-516224-34-00
- EudraCT number
- 2020-005210-18
- ClinicalTrials.gov
- NCT04861558
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Phase I: To determine the maximum tolerated dose of 5-Fluorouracil 24-hour EPIC, in combination with intensified oxaliplatin/irinotecan HIPEC, for treatment of colorectal cancer.
Phase III: To study the recurrence-free survival (RFS) of patients within 24 months
Secondary objectives 3
- Overall and recurrence-free survival up to 5 years.
- Postoperative complication rates within 30 days.
- Quality of life of patients up to 3 years after study treatment.
Conditions and MedDRA coding
Colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10052362 | Metastatic colorectal cancer | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 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.
- Concomitant resectable pulmonary metastases.
- All patients deemed eligible for CRS and HIPEC according to clinical routine.
Exclusion criteria 10
- 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 (ie paraaortal lymph node or bone metastases)
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase I: Maximum tolerated dose of 5-FU 24-hour EPIC, assessed until 30 days post-treatment. Possible toxicity will be reported as Adverse Events.
- Phase III: Local control rate within 24 months – Defined as peritoneal or liver recurrence. Retroperitoneal llg not included in this definition.
Secondary endpoints 3
- To evaluate the overall survival and RFS up to 5 years through the HIPEC registry.
- To evaluate postoperative complication rates within 30 days.
- To evaluate the quality of life of patients up to 3 years after treatment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP1165178 · ATC
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 640 mg/m2 milligram(s)/sq. meter
- Max total dose
- 640 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP139021 · ATC
- Active substance
- Irinotecan Hydrochloride
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 270 mg/m2 milligram(s)/sq. meter
- Max total dose
- 270 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX19 — IRINOTECAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uppsala University
- Sponsor organisation
- Uppsala University
- Address
- Box 256
- City
- Uppsala
- Postcode
- 751 05
- Country
- Sweden
Scientific contact point
- Organisation
- Uppsala University
- Contact name
- Peter Cashin
Public contact point
- Organisation
- Uppsala University
- Contact name
- Peter Cashin
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 163 | 4 |
| Rest of world
India
|
— | 50 | — |
Investigational sites
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department of Surgery, Bla Straket 5, Goteborgs Annedal, Goteborg
Uppsala University Hospital
Gastrointestinal surgery, Ing 70, Akademiska Sjukhuset, 751 85, Uppsala
Karolinska University Hospital
Department of pelvic cancer, Gastrointestinal oncology and colorectal surgical unit, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
Department of Clinical Sciences, Division of Surgery, St. Johns, Fritz Bauers Gata 5, Malmo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2024-08-16 | 2024-08-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516224-34-00_redacted | 5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Adults | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_5-FU_Accord | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_5-FU_Teva | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Irinotecan_Accord | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Irinotecan_Actavis | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Irinotecan_Fresenius Kabi | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE_2024-516224-34 | 5.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-08 | Sweden | Acceptable with conditions 2024-08-16
|
2024-08-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-08 | Sweden | Acceptable 2024-12-20
|
2024-12-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-13 | Sweden | Acceptable 2024-12-20
|
2026-04-13 |