Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02705300
• Other study ID #: FOLFOXIRI-Toco
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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