RMS 2005: a protocol for non metastatic rhabdomyosarcoma

• Conditions: rhabdomyosarcoma no metastatic; MedDRA 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-ES
• Lead Sponsor: Dr Jose Sanchez de Toledo Codina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-15
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

- A pathologically proven diagnosis of Rhabdomyosarcoma.
- No evidence of metastatic lesions.
- Age less than 21 years (20 years and 364 days) of age.
- Previously untreated except for primary surgery.
- No pre-existing illness preventing treatment, in particular renal function must be equivalent to grade 0-1 nephrotoxicity, no prior history of cardiac disease and normal shortening fraction (>
28%) and ejection fraction (> 47%).
- No previous malignant tumours.
- Interval between diagnostic surgery and chemotherapy no longer than 8 weeks.
- Diagnostic material available for pathology review.
- Available for long term follow up through the treatment centre.
- Written informed consent for treatment available.
- stratification according to the High Risk Arm
- age > 6 months (and < 21 years)
- not paratesticular alveolar RMS
- informed consent given for the randomised study
Are the trial subjects under 18? yes
Number of subjects for this age range: 700
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

Any negative response mentioned in the main inclusion criteria will be grounds for ineligibility of the patient.

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 in patients<br>with rhabdomyosarcoma no metastatic included in the High Risk Group;Secondary Objective: To investigate the role of doxorubicin dose intensity and maintenance chemotherapy in patients<br>with rhabdomyosarcoma no metastatic included in the High Risk Group;Primary end point(s): Survival, event-free survival, toxicity;Timepoint(s) of evaluation of this end point: 3 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Survival, event-free survival, toxicity;Timepoint(s) of evaluation of this end point: 3 years