A randomized investigation of side effects to FOLFOXIRI in combination with tocotrienol or placebo as first line treatment of metastatic colorectal cancer.

Phase 1

• Conditions: MedDRA version: 18.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004850-17-DK
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-04
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

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
oTotal bilirubin = 1.5 x ULN
oALAT = 2.5 x ULN (or= 5 x ULN in case of liver metastases)
•Fertile women must present negative pregnancy test. Male patients (with a female fertile partner) as well as women must use secure contraceptives during and 6 months after end of treatment.
•Orally and written informed consent to treatment and biobank
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate toxicity of FOLFOXIRI in combination with tocotrienol or placebo as first line treatment of metastatic colorectal cancer;Secondary Objective: ;Primary end point(s): Time to first serious adverse event (SAE);Timepoint(s) of evaluation of this end point: 6 months after the last patient has finished chemotherapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Number and duration of non-planned hospitalizations from first treatment and 7 months ahead<br>•Response rate<br>•PFS<br>•OS<br>•Toxicity<br>•Quality of life<br>•Resection rate;Timepoint(s) of evaluation of this end point: 6 months after the last patient has finished chemotherapy. <br>This applies to all secondary endpoints.