Treatment of children and young people presenting with non-metastatic rhabdomyosarcoma.

• Conditions: patients in paediatric age (> 6 months & < 21 years old) with localized rhabdomyosarcoma; MedDRA version: 16.0Level: 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-BE
• Lead Sponsor: Hôpital Universitaire Des Enfants Reine Fabiola (H.U.D.E.R.F.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

patients with: a)age > 6 months <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: 576
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
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