Clinical trial · Interventional
Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer
A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer
NCT02705300CI-TRIAL-00080332completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil 3200 mg/m2 | Drug | Fluorouracil | ALIAS |
| Calcium folinate 200 mg/m2 iv | Drug | Immunomodulatory Oligonucleotide | ALIAS |
| Irinotecan 165 mg/m2 iv | Drug | Irinotecan | ALIAS |
| Oxaliplatin 85 mg/m2 iv | Drug | Oxaliplatin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Tocotrienol | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy plus tocotrienol
- description
- 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
- interventionNames
- Drug: Irinotecan 165 mg/m2 iv
- Drug: Oxaliplatin 85 mg/m2 iv
- Drug: Calcium folinate 200 mg/m2 iv
- Drug: 5-fluorouracil 3200 mg/m2
- Dietary Supplement: Tocotrienol
- type
- PLACEBO_COMPARATOR
- label
- Chemotherapy plus placebo
- description
- 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
- interventionNames
- Drug: Irinotecan 165 mg/m2 iv
- Drug: Oxaliplatin 85 mg/m2 iv
- Drug: Calcium folinate 200 mg/m2 iv
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.