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

Not Recruiting

Trial ID: NCT00075582


This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, 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. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.

Official Title

Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

Stanford Investigator(s)


Inclusion Criteria:

   - 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

         - 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 (closed to accrual as of

         - 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

   - Performance status - ECOG 0-2

   - Performance status - Karnofsky 50-100% (≥ 16 years old)

   - Performance status - Lansky 50-100% (< 16 years old)

   - Absolute neutrophil count at least 750/mm^3

   - Platelet count at least 75,000/mm^3 (transfusion independent)

   - Bilirubin no greater than 1.5 times upper limit of normal (ULN)*

   - 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

   - Creatinine clearance* or radioisotope glomerular filtration rate at least 70
   mL/min/1.73 m^2

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - No uncontrolled infection

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

   - Prior steroids allowed

   - No prior radiotherapy


radiation: radiation therapy

drug: cyclophosphamide

drug: vincristine sulfate

procedure: conventional surgery

drug: dactinomycin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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