a protocol for patients with localized rhabdomyosarcoma in pediatric age - EpSSG RMS 2005
- Conditions
- healthy voluntaries are not included in the studyMedDRA version: 14.1Level: PTClassification code 10039022Term: RhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-000217-35-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI PADOVA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
patients with: a)age <21 years; b)pathologically confirmed rhabdomyosarcoma; c) no evidence of metastatic disease; d) previously untreated except for primary surgery.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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
patients with a)age > 21 years; b)metastatic disease; c)previously treated with CT and/or RT; d) pre-existing illness preventing treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the role of doxorubicin dose intensity and maintenance chemotherapy in patients included in the High Risk Group (randomised trial);Secondary Objective: to give an homogeneous local and systemic treatment Europe-wide according to the risk of local and metastatic relapse in patients categorized in Low, Standard and Very High risk Groups (observational study);Primary end point(s): 3 year-event free survival
- Secondary Outcome Measures
Name Time Method