Metastatic colorectal cancer MedDRA version: 8.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Interventions
Trade Name: UFT or Uftoral (UK,DK)
Product Name: UFT
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tegafur
CAS Number: 17902-23-7
Current Sponsor code: EMD135577
Other descriptive name: Ftor
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Both male and female subjects are eligible for randomization. For inclusion in the study, all of the following inclusion criteria must be fulfilled: • Subject has given written informed consent before any study-related activities are carried out • Inpatient or outpatient =18 years of age • Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum • First occurrence of metastatic disease (at presentation not curatively resectable) • Presence of at least one lesion unidimensionally measurable by CT- and/or MRI-scans. (target lesion(s) must not lie within an irradiated area) • Life expectancy of =3 months • Karnofsky performance status of =60 at study entry • White blood cell count (WBC) =3 x 10^9/L, with neutrophils =1.5 x 10^9/L, platelets =100 x 10^9/L, and hemoglobin =9 g/dL • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are not eligible for this study if they fulfill one or more of the following exclusion criteria: • Brain metastasis and/or leptomeningeal disease (known or suspected) • Previous chemotherapy for CRC except adjuvant treatment with progression of disease documented >6 months after end of adjuvant treatment • Previous oxaliplatin-based chemotherapy • Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization • Concurrent or previous chronic systemic immune therapy, targeted therapy, anti-VEGF therapy, or EGFR-pathway targeting therapy not indicated in the study protocol • Concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception • Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia • Peripheral neuropathy >grade 1 • Known hypersensitivity reaction to any of the components of the treatment • Any concurrent malignancy other than basal cell cancer of the skin, or pre-invasive cancer of the cervix (subjects with a previous malignancy but without evidence of disease for =5 years will be allowed to enter the study) • Pregnancy (absence to be confirmed by beta-human choriongonadotrophin [ß-hCG] test) or lactation period • Known drug abuse/alcohol abuse • Legal incapacity or limited legal capacity • Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent • Participation in another clinical study within the 30 days before randomization • Significant disease which, in the investigator’s opinion, would exclude the subject from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the PFS in subjects receiving cetuximab plus either UFOX or FOLFOX-4 as initial treatment for metastatic colorectal cancer.;Secondary Objective: The secondary objectives of this study include the assessment and comparison of: • Response rate (the sum of CR rate and PR rate) in each treatment group • OS in each treatment group • Safety • Quality of Life (QOL), assessed by Functional Assessment of Cancer Therapy–Colorectal (FACT-C), and Euro-QOL (EQ-5D) at each site where appropriate translations of the questionnaires are available and validated, as well as the Therapy Preference Questionnaire (TPQ) • Treatment impact on social daily living and health care resource utilization ;Primary end point(s): The primary variable is progression-free survival. | — |
Countries
Austria, Belgium, France, Germany, Greece, Italy
Outcome results
None listed