Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer
NCT ID: NCT02705300
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2016-05-06
2024-03-27
Brief Summary
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The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Irinotecan 165 mg/m2 iv
Max. 4 months
Oxaliplatin 85 mg/m2 iv
Max. 4 months
Calcium folinate 200 mg/m2 iv
Max. 6 months
5-fluorouracil 3200 mg/m2
Max. 6 months
Tocotrienol
Max. 2 years or at the discretion of the investigator
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
Irinotecan 165 mg/m2 iv
Max. 4 months
Oxaliplatin 85 mg/m2 iv
Max. 4 months
Calcium folinate 200 mg/m2 iv
Max. 6 months
5-fluorouracil 3200 mg/m2
Max. 6 months
Placebo
Max. 2 years or at the discretion of the investigator
Interventions
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Irinotecan 165 mg/m2 iv
Max. 4 months
Oxaliplatin 85 mg/m2 iv
Max. 4 months
Calcium folinate 200 mg/m2 iv
Max. 6 months
5-fluorouracil 3200 mg/m2
Max. 6 months
Tocotrienol
Max. 2 years or at the discretion of the investigator
Placebo
Max. 2 years or at the discretion of the investigator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Vejle Hospital
OTHER
Responsible Party
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Principal Investigators
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Lars H Jensen, PhD
Role: STUDY_CHAIR
Department of Oncology, Vejle Hospital
Louise R Larsen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Oncology, Vejle Hospital
Locations
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Department of Oncology, Vejle Hospital
Vejle, , Denmark
Countries
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Other Identifiers
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FOLFOXIRI-Toco
Identifier Type: -
Identifier Source: org_study_id
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