MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Fluorouracil
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FLUOROURACIL
Other descriptive name: FLUOROURACIL
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histopathologically verified adenocarcinoma of the colon or rectum • Metastatic disease • Planned treatment with FOLFOX or capecitabine combined with bevacizumab • Evaluable disease according to RECIST 1.1 • Performance status 0-2 • Expected survival = 3 months • Patient acceptance to collection of blood samples for translational research • Age = 18 years • 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. • Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): o WBC = 3.0 x 10^9/l or neutrophils (ANC) = 1.5 x 10^9/l o Platelet count = 100 x 10^9/l o Hemoglobin = 6.0 mmol/l o Serum bilirubin = 2.0 x ULN o Serum transaminase = 2.5 x ULN o Serum creatinine = 1.5 ULN • Urine dipstick for protein = 2+, if the dipstick shows protein = 2+, 24 hour urine testing must be performed and show protein contents = 1g. • Written and orally informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: • Other active malignant disease within 5 years prior to inclusion in the study. • Other experimental therapy within 28 days prior to treatment initiation. • Underlying medical disease not adequately treated. • Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab. • Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment • Bleeding tumor • Pregnant or breastfeeding women • Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment. • Hypersensitivity to one or more active substances or auxiliary substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present study is to compare the effect and toxicity of standard chemotherapy and bevacizumab with the same regimen supplemented with tocotrienol in metastatic colorectal cancer.;Secondary Objective: Not applicable;Primary end point(s): The rate of progression free patients at six months;Timepoint(s) of evaluation of this end point: 6 months after enrollment of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Translational research of selected biomarkers 2. Toxicity 3. Time to serious adverse event (SAE) 4. Response rate 5. Overall survival ;Timepoint(s) of evaluation of this end point: 1. 1 year after enrollment of the last patient 2. 6 months after enrollment of the last patient 3. 6 months after enrollment of the last patient 4. 6 months after enrollment of the last patient 5. 2 years after enrollment of the last patient | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit
Vejle Hospital
Outcome results
None listed