International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours
- Conditions
- Ewing's Sarcoma Family of TumoursMedDRA version: 18.1Level: PTClassification code 10015560Term: Ewing's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002107-17-HU
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
• Histologically confirmed ESFT of bone or soft tissue
• Localised or pulmonary and/or pleural metastatic disease
• Age >2 years and <50 years (from second birthday to 49 years 364 days) at the date of diagnostic biopsy
• Randomisation =45 days after diagnostic biopsy/surgery
• Patient assessed as medically fit to receive the treatment in either of the R1 treatment arms
• No prior treatment for ESFT other than surgery
• Documented negative pregnancy test for female patients of childbearing potential
• Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where applicable
• Written informed consent from the patient and/or the parent/legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range: 470
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
• Extrapulmonary metastatic disease
• Contra-indication to the treatment in either of the R1 treatment arms
• Second malignancy
• Pregnant or breastfeeding women
• Follow-up not possible due to social, geographic or psychological reasons
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method