TOCOTRIENOL for Metastatic colorectal cancer

Inclusion criteria

• {"criterion_text":"- Histopathologically verified adenocarcinoma of the colon or rectum\n- Metastatic disease\n- Planned treatment with FOLFOX or capecitabine combined with bevacizumab\n- Evaluable disease according to RECIST 1.1\n- Performance status 0-2\n- Expected survival ≥ 3 months\n- Patient acceptance to collection of blood samples for translational research\n- Age ≥ 18 years\n- Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted.\n- Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):\n - WBC ≥ 3.0 x 109/l or neutrophils (ANC) ≥ 1.5 x 109/l\n - Platelet count ≥ 100 x 109/l\n - Hemoglobin ≥ 6.0 mmol/l\n - Serum bilirubin ≤ 2.0 x ULN\n - Serum transaminase ≤ 2.5 x ULN\n - Serum creatinine ≤ 1.5 ULN\n- Urine dipstick for protein ≤ 2+, if the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents ≤ 1g.\n- Written and orally informed consent"}

Exclusion criteria

• {"criterion_text":"- Other active malignant disease within 5 years prior to inclusion in the study.\n- Other experimental therapy within 28 days prior to treatment initiation.\n- Underlying medical disease not adequately treated.\n- Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab.\n- Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment\n- Bleeding tumor\n- Pregnant or breastfeeding women\n- Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment.\n- Hypersensitivity to one or more active substances or auxiliary substances"}

Primary endpoints

• {"endpoint_text":"- The rate of progression free patients at six months.","definition_or_measurement_approach":"Proportion (rate) of patients who are progression-free at six months (no further definition provided in the record)."}

Denmark

Earliest CTIS Part Ii Submission Date

07-08-2024

Latest Decision Or Authorization Date

27-09-2024

Processing Time Days

51

Number Of Sites

1

Number Of Participants

74

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":"Odense University Hospital","duties_or_roles":"sponsorDuties codes: 1, 7, 8","organisation_type":"Hospital/Clinic/Other health care facility"}