A randomized phase II study of FOLFORI plus or not CETUXIMAB in elderly advanced colorectal cancer patients.
- Conditions
- Elderly mestatic colorectal cancer patients, Wild-type KRAS ,70-80 years of age, ECOG 0-1.MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000477-23-IT
- Lead Sponsor
- AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Diagnosis if hystologically confirmed metastatic Adenocarcinoma of colorectum. Wild-type KRAS tumors. 70-80 years of age. ECOG 0-1
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74
Exclusion Criteria
Dependent for daily living activities. Presence of geriatric syndromes. No previous chemotherapy for metastatic disease. Any investigational agents 4 weeks prior to entry.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the percentage of patients free of disease progression at 6 months.;Secondary Objective: To detrmine the safety of combination of chemotherapy with cetuximab in elderly oatients considering. To determine the percentage of response rate and median survival in both treatment arms.;Primary end point(s): To determine the percentage of patients free of disease progression at 6 months.;Timepoint(s) of evaluation of this end point: 18 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To detrmine the safety of combination of chemotherapy with cetuximab in elderly oatients considering. To determine the percentage of response rate and median survival in both treatment arms.;Timepoint(s) of evaluation of this end point: 18 months