PHASE III TRIAL ON THE EFFICACY OF DOSE`S INTENSIFICATION IN PATIENTS WITH NON METASTATIC EWING`S SARCOMA - ISG/AIEOP EW-1
- Conditions
- HOSPITAL PATIENTS AFFECTED BY EWING`S SARCOMA OR PNET WITH BONE`S INVOLVEMENTMedDRA version: 9.1Level: LLTClassification code 10015560Term: Ewing's sarcoma
- Registration Number
- EUCTR2008-008361-35-IT
- Lead Sponsor
- ISTITUTI ORTOPEDICI RIZZOLI
- 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
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method