Patients with neoplasia malignant. MedDRA version: 14.1 Level: HLT Classification code 10010023 Term: Colorectal neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Glutathione
Concentration unit: mg milligram(s)
Concentration number: 2680-
Pharmaceutical form of the placebo: P
Sponsors
AZIENDA DI RILIEVO NAZIONALE E DI ALTA SPECIALIZZAZIONE OSPEDALE CIVICO E BENFRATELLI, G.DI CRISTINA E M.ASCOLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed