Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
Condition: Adult Rhabdomyosarcoma; Embryonal Childhood Rhabdomyosarcoma; Embryonal-botryoid Childhood Rhabdomyosarcoma; Previously Untreated Childhood Rhabdomyosarcoma
MeSH terms: Rhabdomyosarcoma; Rhabdomyosarcoma, Embryonal
Intervention: conventional surgery; dactinomycin; cyclophosphamide; vincristine sulfate; radiation therapy
Intervention description: Some patients may undergo second-look surgery; Given IV; Given IV; Given IV; Undergo radiotherapy
Intervention MeSH terms: Dactinomycin; Cactinomycin; Cyclophosphamide; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 390.0
Sex: All
Maximum age: 49 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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
                  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 (closed to accrual as of
                  09/23/2011):

                    -  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
             study)

          -  Prior steroids allowed

          -  No prior radiotherapy