HOSPITAL PATIENTS AFFECTED BY EWING`S SARCOMA OR PNET WITH BONE`S INVOLVEMENT MedDRA version: 9.1 Level: LLT Classification code 10015560 Term: Ewing's sarcoma
Conditions
Interventions
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Dactinomycin
Concentration unit: gm/m2 gram(s)/square meter
Concentration type: equal
Concentration number: .0015-
Trade Na
Sponsors
ISTITUTI ORTOPEDICI RIZZOLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: EWING`S SARCOME OR PNET HISTOLOGIC DIAGNOSIS; AGE LESS THAN 40 YEARS OLD; NO EVIDENT METASTASIS OR SINGLE PULMONARY IMAGE LESS THAN 0.5 CM; GOOD MARROW, KIDNEY AND LIVER FUNCTIONS; INFORMED CONSENT Are the trial subjects under 18? yes Number of subjects for this age range: 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: METASTASIS PRESENCE; COUNTER INDICATIOS TO THE USE OF THE DRUGS OF THE TRIAL PROTOCOL; SOCIAL OR PSYCHOLOGICAL CONDITIONS THAT DON`T ASSURE A GOOG COMPLIANCE TO THE TRIAL OR TO THE FOLLOW UP VISIT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: EVALUATING IF THE SUGGESTED TREATMENT, MORE INTENSIVE AND SHORTER THAN THE STANDARD, OFFERS THE SAME CHANCE OF SURVIVAL AS STANDARD PROTOCOL ISG/SSGG III;Secondary Objective: EVALUATING IF AN INTENSIVE TREATMENT CAN INCREASE GOOD RESPONDER PATIENTS`S SHARE IN COMPARISON WITH THE STANDARD TREATMENT;Primary end point(s): EVALUATING NON INFERIORITY OF THE EXPERIMENTAL TREATMENT IN COMPARISON WITH THE STANDARD TREATMENT | — |
Countries
Italy
Outcome results
None listed