Role of the Glutatione reduced in the prevention of neuro-toxicity from Oxaliplatino.

Conditions: Patients with neoplasia malignant.
MedDRA version: 14.1Level: HLTClassification code 10010023Term: Colorectal neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2007-007059-14-IT

Lead Sponsor: AZIENDA DI RILIEVO NAZIONALE E DI ALTA SPECIALIZZAZIONE OSPEDALE CIVICO E BENFRATELLI, G.DI CRISTINA E M.ASCOLI

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

Patients with istological or cytological diagnosis of neoplasia malignant. Presence of measurable and/or valued disease according to criteria RECIST. Age comprised between 18 and 75 years. Performance status => 60 sec. Karnofsky. Expectation of advanced life to 3 months. Adapted reservoir medullary. Adapted hepatic, renal and cardiac functionality. Informed consent written.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous chemotherapy with neurotoxic drugs. Presence of cerebral metastases. Carcinomatosa meningitis. Fibrous interstitial. Interstitial pneumonia. Cardiac lack of balance congestizio or strict arrhythmy or recent coronaric ischemica disease. Women in pregnancy or breast-feeding. Patients with infections in active or not controlled phase, or with known infection HIV. Other concomitant pathologies that contraindicate drugs in study to judgment of the clinician. Inability to supply an informed consent. Impossibility to guarantee the follow-up.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Treatment of the neurotoxicity from Oxaliplatino in patients with neoplasia malignant.;Secondary Objective: Appraisal of eventual therapeutic interferences.;Primary end point(s): Patients with neoplasia malignant.

Secondary Outcome Measures