Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets:

  • Subset 1, defined by meeting 1 of the following criteria (closed to accrual as of 08/13/2010):

    • Stage 1 and clinical group I (completely resected) or II (microscopic residual disease and/or regional lymph node involvement) disease
    • Stage 1 and clinical group III (gross residual disease) disease arising in the orbit
    • Stage 2 and clinical group I or II disease

  • Subset 2, defined by meeting 1 of the following criteria:

    • Stage 1 and clinical group III disease arising in a non-orbit site
    • Stage 3 and clinical group I or II disease

• Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies)

  • If there is extensive gross node involvement only confirmatory node biopsy is recommended and the patient is classified as Clinical Group III
• Prior regional lymph node sampling required for patients with extremity tumors

• None of the following diagnoses:

  • Intermediate-risk embryonal RMS
  • Metastatic embryonal RMS
  • Alveolar RMS
  • Undifferentiated sarcoma
  • RMS not otherwise specified (NOS)
  • Other soft tissue sarcoma, including sarcoma NOS
• Prior enrollment on clinical trial COG-D9902

PATIENT CHARACTERISTICS:

Age

• Under 50

  • No infants who would not be able to receive study radiotherapy, in the opinion of the treating physician

Performance status

• ECOG 0-2 OR
• Karnofsky 50-100% (≥ 16 years old) OR
• Lansky 50-100% (< 16 years old)

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 750/mm^3
• Platelet count at least 75,000/mm^3 (transfusion independent)

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)* NOTE: *Patients with primary hepatic or biliary tumors and bilirubin greater than 1.5 times ULN allowed provided all other eligibility criteria are met

Renal

• Creatinine* based on age/gender as follows:

  • No greater than 0.8 mg/dL for patients age 5 and under
  • No greater than 1.0 mg/dL for patients age 6 to 9
  • No greater than 1.2 mg/dL for patients age 10 to 12
  • No greater than 1.4 mg/dL for female patients age 13 and over
  • No greater than 1.5 mg/dL for male patients age 13 to 15
  • No greater than 1.7 mg/dL for male patients age 16 and over OR
• Creatinine clearance* or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m^2 NOTE: *Patients with tumors obstructing the urinary tract causing elevated creatinine allowed provided all other eligibility criteria are met and unimpeded urinary flow is established via decompression of the obstructed portion of the urinary tract

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy (except for patients treated on the related intermediate-risk study)

Endocrine therapy

• Prior steroids allowed

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics