Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer

Sponsor
Vejle Hospital
Study ID
NCT02705300
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan 165 mg/m2 iv — DRUG
    Max. 4 months
  • Oxaliplatin 85 mg/m2 iv — DRUG
    Max. 4 months
  • Calcium folinate 200 mg/m2 iv — DRUG
    Max. 6 months
  • 5-fluorouracil 3200 mg/m2 — DRUG
    Max. 6 months
  • Tocotrienol — DIETARY_SUPPLEMENT
    Max. 2 years or at the discretion of the investigator
  • Placebo — DRUG
    Max. 2 years or at the discretion of the investigator

Study Details

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.

Key Dates

Start date
May 6, 2016
Status verified
Aug 2024
Primary completion
Aug 31, 2019
Completion
Mar 27, 2024

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy plus 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
  • Placebo Comparator: Chemotherapy plus 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 Measure

Time to first serious adverse event [ Time Frame: 6 months after the last patient has finished chemotherapy ]

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