Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
60,000
Countries
1
Sites
21
Metastatic or locally advanced inoperable colorectal cancer
Primary objective: • To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-24
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520288-15-00
- EudraCT number
- 2011-003158-24
- ClinicalTrials.gov
- NCT01531621
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Primary objective:
• To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection
Secondary objectives 6
- • To assess treatments for mCRC
- • To assess efficacy of chemotherapy and targeted drugs with overall response rates (ORR), failure free survival (FFS), progression free survival (PFS), and overall survival (OS)
- • To radiologically or with machine learning from scans or reports assess tumour sites ,density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria
- • To evaluate whole blood, plasma, serum and tumour block biomarkers and DNA polymorphisms that may predict drug effects, resectability and clinical behaviour of the tumour in the prospective cohort.
- • Biomarker evaluation from diagnostic samples, mainly tumour blocks, in the retrospective data collection study in order to verify diagnosis and predictive & prognostic markers (from prospective clinical trial) in a big population based series.
- • Quality of life and health related qualify of life, Cost-utility, QALY and cost-benefit assessment in the subpopulation of 444/941+1000 patients.
Conditions and MedDRA coding
Metastatic or locally advanced inoperable colorectal cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Inclusion criteria 1. Patients with histologically confirmed CRC, who are scheduled to start or are getting first line chemotherapy for metastatic disease 2. Age 18 years 3. Metastatic disease (including locally advanced disease not amenable with surgery and/or (chemo)radiotherapy) 4. Signed written informed consent form (ICF) according to ICH/GCP and the regulatory authorities' approval will be obtained prior to study 5. No informed consent form will be obtained from patients participating in the data collection study obtaining data from hospital records and Finnish cancer registry and other health registries. No blood sampling, nor contacting of patients will be performed.
Exclusion criteria 1
- No exclusion criteria
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary objective: • To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Capecitabine Orion 500 mg kalvopäällysteiset tabletit
PRD1625261 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2500 mg/m2 milligram(s)/square meter
- Max total dose
- 3000000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- 31392
- MA holder
- ORION CORPORATION
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil Accord 50 mg/ml injektio-/infuusioneste, liuos
PRD1972814 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 2000 mg/m2 milligram(s)/square meter
- Max total dose
- 120000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 23977
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Pia Österlund
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Pia Österlund
Locations
1 EU/EEA country · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 60,000 | 21 |
| Rest of world | — | 0 | — |
Investigational sites
Kymenlaakson keskussairaala
Syövänhoito, Kotkantie 41, 48210, Kotka
Etelae-Karjalan hyvinvointialue
Syövänhoito, Valto Kakelan Katu 3 C, 53130, Lappeenranta
Tampere University Hospital
Syövänhoito, Elamanaukio 2, 33520, Tampere
Länsi-Pohjan keskussairaala
Syövänhoito, Kauppakatu 25, 94100, Kemi
Keski-Pohjanmaan hyvinvointialue
Syövänhoito, Mariankatu 16-20, 67200, Kokkola
Ahvenanmaan keskussairaala
Syövänhoito, Doktorsvägen 1, 22111, Mariehamn
Etelae-Savon hyvinvointialue
Syövänhoito, Porrassalmenkatu 35-37, 50100, Mikkeli
Vaasa Central Hospital
Syövänhoito, Hietalahdenkatu 2-4, 65130, Vaasa
Kuopio University Hospital
Syövänhoito, P. O. Box 1777, 70211, Kuopio
Pohjois-Karjalan hyvinvointialue
Syövänhoito, Tikkamaentie 16, 80210, Joensuu
Central Finland Hospital District Central Finland Hospital Nova
Syövänhoito, Hoitajantie 3, 40620, Jyvaskyla
Etela-Pohjanmaan Sairaanhoitopiiri
Syövänhoito, Hanneksenrinne 7, 60220, Seinajoki
Kanta-Haemeen hyvinvointialue
Syövänhoito, Sibeliuksenkatu 2, 13100, Hameenlinna
HUS-Yhtymae
Syövänhoito, Haartmaninkatu 4, 00290, Helsinki
Savonlinnan keskussairaala
Syövänhoito, Keskussairaalantie 6, 57120, Savonlinna
Oulu University Hospital
Syövänhoito, Kajaanintie 50, 90220, Oulu
Satakunnan hyvinvointialue
Syövänhoito, Sairaalantie 3 Pori Satakunta, 28500, Pori
Kainuu Central Hospital
Syövänhoito, Sotkamontie 13, 87300, Kajaani
Turku University Hospital
Syövänhoito, Kiinamyllynkatu 10, 20520, Turku
Paeijaet-Haemeen hyvinvointialue
Syövänhoito, Keskussairaalankatu 7, 15850, Lahti
Lapland Central Hospital
Syövänhoito, Ounasrinteentie 22, 96400, Rovaniemi
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 |
|---|---|---|---|---|---|
| Finland | 2025-01-25 | 2025-01-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | RAXO_Kysymyspatteristo_FI_250817 | 1 |
| Protocol (for publication) | RAXO_protocol_V4.1_14Dec2025 | 4.1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Version_Secondary_ v4 | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Version_Tertiary_ v4 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | Fluorouracil_valmisteyhteenveto | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Valmisteyhteenveto_kapesitabiini | 2 |
| Synopsis of the protocol (for publication) | Summary and main publication | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-07 | Finland | Acceptable 2025-01-24
|
2025-01-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-01 | Finland | Acceptable 2025-12-18
|
2025-12-19 |