Weekly therapy with Carboplatin and Docetaxel in patients with head-neck cancer with important comorbidity (ancer patients with chronic cardiac or circulatory disorders, people who have had cardiovascular accidents in the past, people with renal failure, etc.).
- Conditions
- Patients with head and neck cancer having high comorbidityMedDRA 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
- EUCTR2011-003509-65-IT
- Lead Sponsor
- ISTITUTO ONCOLOGICO VENETO
- 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
Head and Neck Squamous Cell Carcinoma, High Comorbidity, Adequate bone marrow, hepatic and renal function, Age>18, signed Informed Consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 11
Exclusion Criteria
Psychosis, alcoholism,other cancers,renal or hepatic impairment, inadequate bone marrow function, uncontrolled diabetes mellitus, inadequate left ventricular function.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of Response Rate;Secondary Objective: Analisys of duration of response (DR), Evalutaion of stable disease (SD), Progression Free Survival (PFS), Overall Survival (OS), Evaluation Quality of Life, Toxicity evaluation.;Primary end point(s): Response rate (RR);Timepoint(s) of evaluation of this end point: After two cycles (3 weeks of treatment + 1 week of pause)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Duration of response (DR), Stable Disease (SD), Progression Free Survival (PFS), Overall Survival (OS), Quality of life (QoL), Side effects mesure;Timepoint(s) of evaluation of this end point: After two cycles (3 weeks of treatment + 1 week of pause)