Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT00379457
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed rhabdomyosarcoma (RMS) or other malignant mesenchymal tumor, including undifferentiated soft tissue sarcoma or ectomesenchymoma
* Has undergone diagnostic surgery within the past 8 weeks
* Meets criteria for 1 of the following risk groups:
* Low-risk group
* Localized nonalveolar RMS at any site
* Embryonal, spindle cell, or botryoid RMS (favorable pathology)
* Microscopically completely resected disease (Intergroup Rhabdomyosarcoma Study \[IRS\] group I)
* Negative nodes (N0)
* Tumor size ≤ 5 cm AND age \< 10 years (favorable tumor size and age)
* Standard-risk group, meeting criteria for 1 of the following subgroups:
* Subgroup B
* Localized nonalveolar RMS at any site
* Favorable pathology
* Microscopically completely resected disease (IRS group I)
* N0 disease
* Tumor size \> 5 cm OR age ≥ 10 years (unfavorable tumor size or age)
* Subgroup C
* Localized nonalveolar RMS in orbit, head and neck nonparameningeal sites, or genitourinary (GU) non bladder prostate (i.e., paratesticular and vagina/uterus) sites (favorable site)
* Favorable pathology
* Microscopic residual disease (pT3a) or completely resected disease with nodal involvement (N1) (IRS group II) OR macroscopic residual disease (pT3b) (IRS group III)
* N0 disease
* Any tumor size or age
* Subgroup D
* Localized nonalveolar RMS in parameningeal sites, extremities, GU bladder prostate sites, or other sites (unfavorable site)
* Favorable pathology
* IRS group II or III
* N0 disease
* Favorable tumor size and age
* High-risk group, meeting criteria for 1 of the following subgroups:
* Subgroup E
* Localized nonalveolar RMS at unfavorable site
* Favorable pathology
* IRS group II or III
* N0 disease
* Unfavorable tumor size or age
* Subgroup F
* Localized nonalveolar RMS at any site
* Favorable pathology
* IRS group I, II, or III
* Positive nodes (N1)
* Any tumor size or age
* Subgroup G
* Localized alveolar RMS at any site
* Alveolar RMS, including the solid-alveolar variant (unfavorable pathology)
* IRS group I, II, or III
* N0 disease
* Any tumor size or age
* Very high-risk group
* Localized alveolar RMS at any site
* Unfavorable pathology
* IRS group I, II, or III
* N1 disease
* Any tumor size or age
* Previously untreated disease (except for primary surgery)
* No evidence of metastatic disease
PATIENT CHARACTERISTICS:
* Shortening fraction \> 28%
* Ejection fraction \> 47%
* No prior cardiac disease
* Renal function must be equivalent to grade 0-1 nephrotoxicity
* No prior malignant tumors
* No pre-existing illness preventing treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
20 Years
Study:
NCT00379457
Study Brief:
Protocol Section:
NCT00379457