EUCTR2015-004850-17-DK
Active, not recruiting
Phase 1
A randomized investigation of side effects to FOLFOXIRI in combination with tocotrienol or placebo as first line treatment of metastatic colorectal cancer.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vejle Hospital
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 year
- •PS 0\-1\. If age 71\-75, then PS 0
- •Life expectancy \> 3 months
- •Organ and bone marrow function as follows:
- •oNeutrofile count \= 1\.5 x 10^9/L
- •oThrombocytes \= 100 x 10^9/L
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\-FU, calcium folinate, oxaliplatin, irinotecan or capecitabine.
- •Hypersensitivity to one or more of the active substances or auxilliary agents
Outcomes
Primary Outcomes
Not specified
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