Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma.

PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Dactinomycin; Sargramostim; Vincristine

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