NCT02705300CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 29 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 26 Feb 2016
- Start date
- 6 May 2016
- Primary completion date
- Aug 2019
- Lead sponsor
- Vejle Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT02705300
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 70
- From 6 May 2016 to the primary completion date, Aug 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chemotherapy, radiotherapy or immunotherapy within 4 weeks
- Other concurrent malignant disease other than non-melanoma skin cancer
Other illness
- Serious competitive medical condition
- Hypersensitivity to one or more of the active substances or auxilliary agents
Lab values
- Previous serious and unexpected reactions to 5-fluorouracil, calcium folinate, oxaliplatin, irinotecan or capecitabine.
Other
- Primarily resectable metastases
- Known neuropathy ≥ grade 2
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Oncology, Vejle Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.