Clinical trial • Phase III • Oncology
CAPECITABINE for Colon cancer
Phase III trial of CAPECITABINE for Colon cancer. 247 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colon cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-08-2024
- First CTIS Authorization Date
- 27-09-2024
Trial design
Phase III trial across 7 sites in Denmark, Norway.
- Target Sample Size
- 247
- Trial Duration For Participant
- 730
Eligibility
Recruits 247 isVulnerablePopulationSelected: true. Written and orally informed consent is required. Subject information and informed consent form documents are listed (L1_SIS and ICF for Norway and for all sites). No additional details on assent, capacity assessment, or age-specific consent procedures are provided in the available record..
- Pregnancy Exclusion
- Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
- Vulnerable Population
- isVulnerablePopulationSelected: true. Written and orally informed consent is required. Subject information and informed consent form documents are listed (L1_SIS and ICF for Norway and for all sites). No additional details on assent, capacity assessment, or age-specific consent procedures are provided in the available record.
Inclusion criteria
- {"criterion_text":"- Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan."}
- {"criterion_text":"- Age ≥ 18 years"}
- {"criterion_text":"- PS 0-2."}
- {"criterion_text":"- Hematology ANC ≥1.5x109/l. Thrombocytes ≥ 100x109/l."}
- {"criterion_text":"- Biochemistry Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal value"}
- {"criterion_text":"- Consent to translational research"}
- {"criterion_text":"- Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment."}
- {"criterion_text":"- Written and orally informed consent."}
Exclusion criteria
- {"criterion_text":"- Patients with distant metastases."}
- {"criterion_text":"- Acute operation"}
- {"criterion_text":"- Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before inclusion."}
- {"criterion_text":"- Active, serious infection or other serious disease."}
- {"criterion_text":"- Peripheral neuropathy NCI grade > 1"}
- {"criterion_text":"- Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri."}
- {"criterion_text":"- Other investigational treatment within 30 days prior to treatment start."}
- {"criterion_text":"- Hypersensitivity to one or more of the active or auxiliary substances."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Two-year disease free survival","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 247
- Recruitment Window Months
- 159
- Consent Approach
- Written and orally informed consent required. Subject information and informed consent form documents are provided (L1_SIS and ICF documents exist for Norway and for all sites). No details provided on assent, age-specific consent documents or languages in the available record.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 247
Denmark
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 27-09-2024
- Processing Time Days
- 11
- Number Of Sites
- 6
- Number Of Participants
- 193
Sites
- Site Name
- Nordsjællands Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Fahimeh Andersen
- Contact Person Email
- fahimeh.andersen@regionh.dk
- Site Name
- Lillebaelt Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Lars Henrik Jensen
- Contact Person Email
- lars.henrik.jensen@rsyd.dk
- Site Name
- Region Hovedstaden
- Department Name
- Department of Oncology
- Contact Person Name
- Laura Vittrup Diness
- Contact Person Email
- laura.vittrup.diness@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Mette Yilmaz
- Contact Person Email
- m.yilmaz@rn.dk
- Site Name
- Sygehus Soenderjylland Soenderborg
- Department Name
- Department of Oncology
- Contact Person Name
- Daniela Zitnjak
- Contact Person Email
- Daniela.Zitnjak@rsyd.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Contact Person Name
- Lone Nørgaard
- Contact Person Email
- Lone.Noergaard.Petersen@regionh.dk
Norway
- Earliest CTIS Part Ii Submission Date
- 26-09-2024
- Latest Decision Or Authorization Date
- 02-10-2024
- Processing Time Days
- 6
- Number Of Sites
- 1
- Number Of Participants
- 54
Sites
- Site Name
- Helse Bergen HF
- Department Name
- Department of Oncology
- Contact Person Name
- Olav Dahl
- Contact Person Email
- olav@dahlpost.no
Sponsor
Primary sponsor
- Full Name
- Lillebaelt Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"University of Southern Denmark","duties_or_roles":"","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- CAPECITABINE
- Active Substance
- CAPECITABINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- maxDailyDoseAmount: 2000 mg/m2; maxTotalDoseAmount: 224000 mg/m2
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRACAVERNOUS USE
- Route
- INTRACAVERNOUS USE
- Maximum Dose
- maxDailyDoseAmount: 130 mg/m2; maxTotalDoseAmount: 1040 mg/m2
- Combination Treatment
- Yes
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