Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
Condition: Adult Rhabdomyosarcoma; Childhood Alveolar Rhabdomyosarcoma; Childhood Botryoid-Type Embryonal Rhabdomyosarcoma; Childhood Embryonal Rhabdomyosarcoma; Localized Childhood Soft Tissue Sarcoma; Rhabdomyosarcoma; Sarcoma; Stage I Adult Soft Tissue Sarcoma AJCC v7; Stage II Adult Soft Tissue Sarcoma AJCC v7; Stage III Adult Soft Tissue Sarcoma AJCC v7
MeSH terms: Sarcoma; Rhabdomyosarcoma; Rhabdomyosarcoma, Alveolar; Rhabdomyosarcoma, Embryonal
Intervention: Cyclophosphamide; Dactinomycin; Irinotecan Hydrochloride; Laboratory Biomarker Analysis; Questionnaire Administration; Radiation Therapy; Vincristine Sulfate
Intervention description: Given IV; Given IV; Given IV; Correlative studies; Ancillary studies; Undergo radiotherapy; Given IV
Intervention MeSH terms: Dactinomycin; Cactinomycin; Cyclophosphamide; Irinotecan; Vincristine; Camptothecin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 481.0
Sex: All
Maximum age: 49 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

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