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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT00002995
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed embryonal (EMB) rhabdomyosarcoma (RMS) or botryoid or spindle cell variants of EMB RMS or embryonal ectomesenchymoma meeting 1 of the following criteria:
* Stage 1, no clinical group IV: Tumor in favorable site (orbit, head and neck \[excluding parameningeal\], genitourinary \[not bladder/prostate\], or biliary tract) and no metastatic disease
* Stage 2 or 3, clinical group I or II: Tumor in unfavorable site (bladder/prostate, extremity, cranial parameningeal, trunk, retroperitoneum, pelvis, perineal/perianal, intrathoracic, gastrointestinal, or liver), no gross residual disease after initial surgery, and no metastatic disease
* Must have ipsilateral lymph node dissection if age 10 or over with primary paratesticular cancer OR under age 10 with clinically positive regional lymph nodes
* Low risk of recurrence
* Previously untreated disease
* No alveolar RMS or undifferentiated sarcoma
* No intermediate-risk disease
* No metastatic disease at diagnosis
PATIENT CHARACTERISTICS:
Age:
* Under 50
Performance status:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin elevation secondary to biliary or hepatic primaries allowed
Renal:
* Creatinine elevation secondary to tumor obstruction allowed
Other:
* No uncontrolled infection
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
49 Years
Study:
NCT00002995
Study Brief:
Protocol Section:
NCT00002995