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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02705300
Other study ID # FOLFOXIRI-Toco
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 6, 2016
Est. completion date March 2025

Study information

Verified date August 2023
Source Vejle Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date March 2025
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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
Dietary Supplement:
Tocotrienol
Max. 2 years or at the discretion of the investigator
Drug:
Placebo
Max. 2 years or at the discretion of the investigator

Locations

Country Name City State
Denmark Department of Oncology, Vejle Hospital Vejle

Sponsors (1)

Lead Sponsor Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first serious adverse event 6 months after the last patient has finished chemotherapy
Secondary Number of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy 6 months after the last patient has finished chemotherapy
Secondary Duration of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy 6 months after the last patient has finished chemotherapy
Secondary Death during treatment calculated from date of first treatment until 1 month after completed chemotherapy 6 months after the last patient has finished chemotherapy
Secondary Response rate 6 months after the last patient has finished chemotherapy
Secondary Progression free survival 6 months after the last patient has finished chemotherapy
Secondary Overall survival 6 months after the last patient has finished chemotherapy
Secondary Number of patients with treatment related adverse events as assessed by CTCAE v.4.0 6 months after the last patient has finished chemotherapy
Secondary Quality of life as measured by combined questionnaire consisting of EORTC QLQ-C30 and CR29 6 months after the last patient has finished chemotherapy
Secondary Resection rate 6 months after the last patient has finished chemotherapy
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