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A randomized phase II study of FOLFORI plus or not CETUXIMAB in elderly advanced colorectal cancer patients.

A randomized phase II study of FOLFORI plus or not CETUXIMAB in elderly advanced colorectal cancer patients. - FOCETELD

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000477-23-IT
Enrollment
Unknown
Registered
2012-04-02
Start date
2012-04-30
Completion date
Unknown
Last updated
2014-01-27

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

Conditions

Elderly mestatic colorectal cancer patients, Wild-type KRAS ,70-80 years of age, ECOG 0-1. MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: ERBITUX*INFUS 1FL 10ML 5MG/ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: CETUXIMAB CAS Number: 205923-56-4 Current Sponsor code: NA Other descriptive name: NA Concentr

Sponsors

AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Italy

Contacts

Public ContactClinica di Oncologia Medica

A.O. Ospedali Riuniti di Ancona

s.cascinu@univpm.it071.5964169

Outcome results

None listed

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