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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.).

Weekly therapy with Carboplatin and Docetaxel in patients with head-neck cancer with important comorbidity - HK2010

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003509-65-IT
Enrollment
Unknown
Registered
2012-03-07
Start date
2011-07-18
Completion date
Unknown
Last updated
2012-09-25

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

Conditions

Patients with head and neck cancer having high comorbidity 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

Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CARBOPLATIN CAS Number: 41575-94-4 Current Sponsor code: NA Other descriptive name: Carboplatin Concentration number: NA

Sponsors

ISTITUTO ONCOLOGICO VENETO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Psychosis, alcoholism,other cancers,renal or hepatic impairment, inadequate bone marrow function, uncontrolled diabetes mellitus, inadequate left ventricular function.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)—

Countries

Italy

Contacts

Public ContactSEGRETERIA COMITATO ETICO

ISTITUTO ONCOLOGICO VENETO - I.R.C.C.S.

comitato.etico@ioveneto.it00390438215946

Outcome results

None listed

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