Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer
Phase 2
Completed
- Conditions
- Colorectal Cancer
- Interventions
- Dietary Supplement: TocotrienolDrug: Placebo
- Registration Number
- NCT02705300
- Lead Sponsor
- Vejle Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy plus tocotrienol Irinotecan 165 mg/m2 iv Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Tocotrienol 300 mg x 3 daily Chemotherapy plus tocotrienol Oxaliplatin 85 mg/m2 iv Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Tocotrienol 300 mg x 3 daily Chemotherapy plus tocotrienol Calcium folinate 200 mg/m2 iv Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Tocotrienol 300 mg x 3 daily Chemotherapy plus tocotrienol Tocotrienol Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Tocotrienol 300 mg x 3 daily Chemotherapy plus placebo Oxaliplatin 85 mg/m2 iv Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Placebo x 3 daily Chemotherapy plus tocotrienol 5-fluorouracil 3200 mg/m2 Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Tocotrienol 300 mg x 3 daily Chemotherapy plus placebo Irinotecan 165 mg/m2 iv Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Placebo x 3 daily Chemotherapy plus placebo Calcium folinate 200 mg/m2 iv Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Placebo x 3 daily Chemotherapy plus placebo 5-fluorouracil 3200 mg/m2 Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Placebo x 3 daily Chemotherapy plus placebo Placebo Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Placebo x 3 daily
- Primary Outcome Measures
Name Time Method Time to first serious adverse event 6 months after the last patient has finished chemotherapy
- Secondary Outcome Measures
Name Time Method 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 Number of patients with treatment related adverse events as assessed by CTCAE v.4.0 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 Progression free survival 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 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 Response rate 6 months after the last patient has finished chemotherapy Overall survival 6 months after the last patient has finished chemotherapy Resection rate 6 months after the last patient has finished chemotherapy
Trial Locations
- Locations (1)
Department of Oncology, Vejle Hospital
🇩🇰Vejle, Denmark