Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

Not Recruiting

Trial ID: NCT00354835


This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.

Official Title

Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)

Stanford Investigator(s)


Inclusion Criteria:

   - Patients with newly diagnosed embryonal RMS, botryoid or spindle cell variants of
   embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study

   - Enrollment on COG-D9902 to confirm local histologic diagnosis with central pathology
   review is required for all patients

   - Patients may be enrolled on ARST0531 and start protocol treatment prior to receipt of
   central pathology review results

   - Patient must have Intermediate-risk RMS defined as:

      - Embryonal, botryoid, or spindle cell RMS, or ectomesenchymoma: stage 2 or 3 and
      group III OR

      - Alveolar RMS: stage 1-3 and group I-III

   - Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) is required for all
   patients >= 10 years of age with paratesticular tumors and for patients < 10 years
   with clinically or radiographically involved lymph nodes (except when extensive lymph
   node involvement, defined as two or more lymph nodes > 2 cm in dimension, is
   identified by imaging studies)

   - Regional lymph node sampling or sentinel lymph node procedure is required for
   histologic evaluation in patients with extremity tumors

   - Clinically or radiographically enlarged nodes should be sampled for histologic

   - Detection of metastasis by optional FDG PET (not required for study enrollment); FDG
   PET may detect abnormalities suggestive of metastasis not identified by bone scan,
   computed tomography (CT), or bone marrow aspiration/biopsy; the prognostic
   significance of FDG PET-detected abnormalities is not clear; FDG PET-detected
   abnormalities MUST be confirmed to be metastases by an additional imaging modality
   (such as magnetic resonance imaging [MRI] or CT) OR pathologic confirmation; unless
   FDG PET abnormalities are confirmed by another imaging modality or biopsy, FDG PET
   abnormalities will NOT be considered evidence of metastasis

   - Patients must have a performance status of 0, 1, or 2; the Lansky performance score
   should be used for patients < 16 years and the Karnofsky performance score for
   patients >= 16 years

   - Patients who have received prior chemotherapy (excluding steroids) or radiation
   therapy, except for patients transferring from ARST0331 (low-risk study), are not

   - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
   ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

      - 1 month to < 6 months: 0.4 mg/dL

      - 6 months to < 1 year: 0.5 mg/dL

      - 1 to < 2 years: 0.6 mg/dL

      - 2 to < 6 years: 0.8 mgt/dL

      - 6 to < 10 years: 1 mg/dL

      - 10 to < 13 years: 1.2 mg/dL

      - 13 to < 16 years: 1.5 mg/dL (males) or 1.4 mg/dL (females)

      - >= 16 years: 1.7 mg/dL (males) or 1.4 mg/dL (females)

   - Patients with urinary tract obstruction by tumor must meet the renal function criteria
   AND must have unimpeded urinary flow established via decompression of the obstructed
   portion of the urinary tract

   - Total bilirubin =< 1.5 x upper limit of normal for age

   - Peripheral absolute neutrophil count (ANC) >= 750/uL

   - Platelet count >= 75,000/uL (transfusion independent)

   - No evidence of uncontrolled infection

   - Patients must be able to undergo radiation therapy, if necessary, as specified in the

   - Female patients of childbearing potential must have a negative pregnancy test

   - Female patients who are breast feeding must agree to stop breast feeding

   - Sexually active patients of childbearing potential must be willing to use effective
   contraception during therapy and for at least 1 month after treatment is completed

   - All patients and/or their parents or legal guardians must sign a written informed

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met


biological: dactinomycin

drug: irinotecan hydrochloride

drug: vincristine sulfate

radiation: radiation therapy

drug: cyclophosphamide

other: questionnaire administration

other: laboratory biomarker analysis

Not Recruiting

Contact Information

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

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