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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004850-17-DK

Enrollment

Registered

2016-01-04

Start date

2016-02-19

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 18.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864

Interventions

Product Name: Irinotecan Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: Irinotecan Other descriptive name: IRINOTECAN HYDROCHLORIDE TRIHYDRATE Concentratio

Eligibility

Sex/Gender

All

Inclusion 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: o Neutrofile count = 1.5 x 10^9/L o Thrombocytes = 100 x 10^9/L o Total bilirubin = 1.5 x ULN o ALAT = 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

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Denmark

Contacts

Public ContactClinical Trial Unit

Vejle Hospital

kfe.onko@rsyd.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026