A protocol for non metastatic rhabdomyosarcoma

Phase 1

• Conditions: Rhabdomyosarcoma in children and young people; MedDRA version: 20.0 Level: PT Classification code 10039022 Term: Rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-000217-35-IE
• Lead Sponsor: Children's Health Ireland at Crumlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

Observational study
Patients with pathologically confirmed rhabdomyosarcoma
Age 0 to < 21 years
Previously untreated except for primary surgery
Diagnostic material available for pathology review
Interval between diagnostic surgery and start of chemotherapy no longer than 8 weeks
No previous malignant tumours
No evidence of metastatic disease (except for those patients eligible for the metastatic arm of the observational study)
Available for long term follow up through the treatment centre
Written informed consent

Investigational study (randomised trial)
Eligible for the protocol and stratified to the High Risk Group
Age > 6 months (younger children are eligible for the protocol study treatment but they will not enter in the randomised trial)
Informed consent given for the randomised study.
Additional criterion for the second randomisation: patient in complete remission or with minimal abnormalities at the end of standard treatment.

Adults >21 years with RMS may be eligible for registration and standard treatment on study but not for randomisation.

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Failure to meet the stated inclusion criteria.
(NB. patients with evidence of metastatic disease and fulfilling all other inclusion criteria are eligible for the metastatic arm of the protocol)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified