Colorectal Cancer
Conditions
Brief summary
Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization. The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization.
Interventions
DRUGIrinotecan 165 mg/m2 iv
Max. 4 months
DRUGOxaliplatin 85 mg/m2 iv
Max. 4 months
DRUGCalcium folinate 200 mg/m2 iv
Max. 6 months
DRUG5-fluorouracil 3200 mg/m2
Max. 6 months
DIETARY_SUPPLEMENTTocotrienol
Max. 2 years or at the discretion of the investigator
DRUGPlacebo
Max. 2 years or at the discretion of the investigator
Sponsors
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically verified colorectal adenocarcinoma. * Patients to receive first line treatment of metastatic disease, including potentially resectable or non-resectable disease * \> 6 months without recurrence after end of adjuvant chemotherapy for radically treated stage II or III colorectal cancer * Disease evaluable according to RECIST 1.1, but not necessarily measurable disease. * Age 18-75 years * Performance status (PS) 0-1. If age 71-75, then PS 0 * Life expectancy \> 3 months * Organ and bone marrow function as follows: * Neutrophil count ≥ 1.5 x 10\^9/L * Thrombocytes ≥ 100 x 10\^9/L * Total bilirubin ≤ 1.5 x upper level of normal (ULN) * Alanine transaminase (ALAT) ≤ 2.5 x ULN (or≤ 5 x ULN in case of liver metastases) * Fertile women must present negative pregnancy test. Male (with a female fertile partner) as well as female patients must use secure contraceptives during and 6 months after end of treatment. * Orally and written informed consent to treatment and biobank
Exclusion criteria
* Primarily resectable metastases * Chemotherapy, radiotherapy or immunotherapy within 4 weeks * Known neuropathy ≥ grade 2 * Serious competitive medical condition * Other concurrent malignant disease other than non-melanoma skin cancer * Previous serious and unexpected reactions to 5-fluorouracil, calcium folinate, oxaliplatin, irinotecan or capecitabine. * Hypersensitivity to one or more of the active substances or auxilliary agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first serious adverse event | 6 months after the last patient has finished chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Duration of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy | 6 months after the last patient has finished chemotherapy |
| Death during treatment calculated from date of first treatment until 1 month after completed chemotherapy | 6 months after the last patient has finished chemotherapy |
| Response rate | 6 months after the last patient has finished chemotherapy |
| Progression free survival | 6 months after the last patient has finished chemotherapy |
| Number of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy | 6 months after the last patient has finished chemotherapy |
| Number of patients with treatment related adverse events as assessed by CTCAE v.4.0 | 6 months after the last patient has finished chemotherapy |
| Quality of life as measured by combined questionnaire consisting of EORTC QLQ-C30 and CR29 | 6 months after the last patient has finished chemotherapy |
| Resection rate | 6 months after the last patient has finished chemotherapy |
| Overall survival | 6 months after the last patient has finished chemotherapy |
Countries
Denmark
Outcome results
None listed