retinoblastoma MedDRA version: 6.1 Level: PT Classification code 10038916
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Vincristine
CAS Number: 2068-78-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical
Sponsors
A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the patients affected by retinoblastoma not pretreated unilateral or bilateral of every age and sex. All the patients affected by retinoblastoma which followed the diagnostic program scheduled Are the trial subjects under 18? yes Number of subjects for this age range: 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: all the patients non affected by retinoblastoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Protocol RB 05 aims to unify and standardize clinical and strumental diagnosis criteria, clinical and anatomopathological stadiation and treatment of such tumor.;Secondary Objective: The main objectives of the trial are the following: 1.1 to improve the diagnostic and therapeutic standard for retinoblastoma in Italy, starting a prospective study on one Homogeneous population of patients for diagnosis, stadiation criteria and therapy response criteria. 1.2 To check effectiveness of antiblastic chemotherapy in delaying the possible enucleation and reducing a) the enucleate patients percentage; b) the late metastasis percentage 1.3 To check the role of the chemotherapy in preventing metastasis in the enucleate patients with high risk istoprognostic factors, comparing the results with an historical group of control 1.4 To estimate the prognostic importance of clinical and instrumental factors to the diagnosis 1.5 To estimate perspectively the ophthalmoscopic patterns of neoplastic regression in order to pursue better correlation between the morphologies observed and the variable ones: - Tumor site - Tumor dimensions - Type and importance of treatment;Primary end point(s): to improve the diagnostic and therapeutic standard for retinoblastoma in Italy, starting a prospective study on one Homogeneous population of patients for diagnosis, stadiation criteria and therapy response criteria. | — |
Countries
Italy
Outcome results
None listed