Clinical trial • Phase IV • Oncology

CAPECITABINE for Metastatic colorectal cancer | Locally advanced inoperable colorectal cancer

Phase IV trial of CAPECITABINE for Metastatic colorectal cancer | Locally advanced inoperable colorectal cancer. None/Not specified-controlled.

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Metastatic colorectal cancer | Locally advanced inoperable colorectal cancer
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 07-01-2025
First CTIS Authorization Date: 24-01-2025

Trial design

None/Not specified-controlled Phase IV trial across 21 sites in Finland.

Comparator: None/Not specified
Real World Control: Yes
Target Sample Size: 60000

Eligibility

Recruits 60000 Vulnerable population not selected. Study enrols adults (Age ≥ 18 years) and requires signed written informed consent (ICF) according to ICH/GCP and regulatory approval prior to participation. For the separate data collection component using hospital records, the Finnish cancer registry and other health registries, no informed consent will be obtained and no patient contact or blood sampling will be performed..

Vulnerable Population: Vulnerable population not selected. Study enrols adults (Age ≥ 18 years) and requires signed written informed consent (ICF) according to ICH/GCP and regulatory approval prior to participation. For the separate data collection component using hospital records, the Finnish cancer registry and other health registries, no informed consent will be obtained and no patient contact or blood sampling will be performed.

Inclusion criteria

{"criterion_text":"- Inclusion criteria 1.\tPatients with histologically confirmed CRC, who are scheduled to start or are getting first line chemotherapy for metastatic disease\n- 2.\tAge  18 years\n- 3. Metastatic disease (including locally advanced disease not amenable with surgery and/or (chemo)radiotherapy)\n- 4.\tSigned written informed consent form (ICF) according to ICH/GCP and the regulatory authorities' approval will be obtained prior to study\n- 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

{"criterion_text":"- No exclusion criteria"}

Endpoints

Primary endpoints

{"endpoint_text":"- Primary objective: •\tTo assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection","definition_or_measurement_approach":"Assessment of clinical behaviour, overall resectability, postoperative morbidity and outcomes after resection as described in the primary objective; no additional specific measurement definitions or timepoints are provided in the CTIS record."}

Recruitment

Registry Or Advocacy Recruitment: True: Finnish Cancer Registry and other health registries
Planned Sample Size: 60000
Recruitment Window Months: 291
Consent Approach: Signed written informed consent (ICF) according to ICH/GCP and regulatory authorities' approval will be obtained prior to study for participants in the prospective cohort. For subjects included in the separate data collection study using hospital records, the Finnish cancer registry and other health registries, no informed consent will be obtained and no blood sampling or patient contact will be performed.

Geography

Total Number Of Sites: 21
Total Number Of Participants: 60000

Finland

Earliest CTIS Part Ii Submission Date: 18-12-2024
Latest Decision Or Authorization Date: 19-12-2025
Processing Time Days: 366
Number Of Sites: 21
Number Of Participants: 60000

Sites

Site Name: Ahvenanmaan keskussairaala
Department Name: Syövänhoito
Contact Person Name: Renee Lindvall-andersson
Contact Person Email: renee.lindvall-andersson@ahx.fi

Site Name: Vaasa Central Hospital
Department Name: Syövänhoito
Contact Person Name: Ravichandra Ravi
Contact Person Email: ravichandra.ravi@ovph.fi

Site Name: Länsi-Pohjan keskussairaala
Department Name: Syövänhoito
Contact Person Name: Viktor Wichmann
Contact Person Email: viktor.wichmann@mehilainen.fi

Site Name: Kuopio University Hospital
Department Name: Syövänhoito
Contact Person Name: Annamarja Lamminmaki
Contact Person Email: annamarja.lamminmaki@pshyvinvointialue.fi

Site Name: Paeijaet-Haemeen hyvinvointialue
Department Name: Syövänhoito
Contact Person Name: Krista Honkonen
Contact Person Email: krista.honkonen@paijatha.fi

Site Name: Satakunnan hyvinvointialue
Department Name: Syövänhoito
Contact Person Name: Kalevi Pulkkanen
Contact Person Email: kalevi.pulkkanen@sata.fi

Site Name: Kainuu Central Hospital
Department Name: Syövänhoito
Contact Person Name: Anna Hakalahti
Contact Person Email: anna.hakalahti@kainuu.fi

Site Name: HUS-Yhtymae
Department Name: Syövänhoito
Contact Person Name: Antti Hosio
Contact Person Email: antti.hosio@hus.fi

Site Name: Oulu University Hospital
Department Name: Syövänhoito
Contact Person Name: Raija Kallio
Contact Person Email: raija.kallio@pohde.fi

Site Name: Kanta-Haemeen hyvinvointialue
Department Name: Syövänhoito
Contact Person Name: Petri Nokisalmi
Contact Person Email: petri.nokisalmi@omahame.fi

Site Name: Kymenlaakson keskussairaala
Department Name: Syövänhoito
Contact Person Name: Anneli Sainast
Contact Person Email: anneli.sainast@kymenhva.fi

Site Name: Etelae-Karjalan hyvinvointialue
Department Name: Syövänhoito
Contact Person Name: Mari Metso-Lintula
Contact Person Email: mari.metso-lintula@ekhva.fi

Site Name: Turku University Hospital
Department Name: Syövänhoito
Contact Person Name: Annika Algårs
Contact Person Email: annika.algars@varha.fi

Site Name: Central Finland Hospital District Central Finland Hospital Nova
Department Name: Syövänhoito
Contact Person Name: Kaija Vasala
Contact Person Email: kaija.vasala@hyvaks.fi

Site Name: Lapland Central Hospital
Department Name: Syövänhoito
Contact Person Name: Svea Vaarala
Contact Person Email: svea.vaarala@lapha.fi

Site Name: Tampere University Hospital
Department Name: Syövänhoito
Contact Person Name: Pia Österlund
Contact Person Email: pia.osterlund@pirha.fi

Site Name: Etela-Pohjanmaan Sairaanhoitopiiri
Department Name: Syövänhoito
Contact Person Name: Elina Kaprio
Contact Person Email: elina.kaprio@hyvaep.fi

Site Name: Pohjois-Karjalan hyvinvointialue
Department Name: Syövänhoito
Contact Person Name: Liisa Sailas
Contact Person Email: liisa.sailas@siunsote.fi

Site Name: Keski-Pohjanmaan hyvinvointialue
Department Name: Syövänhoito
Contact Person Name: Anna Sjöstrand
Contact Person Email: anna.sjostrand@soite.fi

Site Name: Savonlinnan keskussairaala
Department Name: Syövänhoito
Contact Person Name: Vesa Kataja
Contact Person Email: vesa.kataja@etelasavonha.fi

Site Name: Etelae-Savon hyvinvointialue
Department Name: Syövänhoito
Contact Person Name: Vesa Kataja
Contact Person Email: vesa.kataja@etelasavonha.fi

Sponsor

Primary sponsor

Full Name: HUS-Yhtymae
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Finland

Investigational products

Investigational Product Name: Capecitabine Orion 500 mg kalvopäällysteiset tabletit
Active Substance: CAPECITABINE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Marketing authorisation / Authorised (product listed with marketing authorisation details)
Maximum Dose: 2500 mg/m2 (max daily dose amount)

Investigational Product Name: Fluorouracil Accord 50 mg/ml injektio-/infuusioneste, liuos
Active Substance: FLUOROURACIL
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: Marketing authorisation / Authorised (product listed with marketing authorisation details)
Maximum Dose: 2000 mg/m2 (max daily dose amount)

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