Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
conventional surgery
+ dactinomycin
+ cyclophosphamide
Myosarcoma+5
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: September 4, 2004
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVES: I. Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine (V), dactinomycin (A), cyclophosphamide (C), and radiotherapy. SECONDARY OBJECTIVES: I. Determine local control rates in patients treated with this regimen. II. Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis (clinical group III) and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with microscopic tumor only and evaluate the pathologic significance of that residual tumor. III. Determine the local control rates in patients with clinical group III disease treated with response-adjusted radiotherapy doses after second-look surgical resection. OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group. REGIMEN I (subset 1 patients) \[closed to accrual as of 08/13/2010: Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin\* IV over 1 minute on day 1 of weeks 13, 16, 19, and 22; and radiotherapy\*\*, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. REGIMEN II (subset 2 patients)\[closed to accrual as of 9/23/2011\]: Patients receive VAC chemotherapy and radiotherapy\*\* as in regimen I and VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin\* IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46. Patients with clinical group III disease may undergo second-look surgery at week 13 followed by response-adjusted radiotherapy, and continued VA\* chemotherapy. In both regimens, treatment continues in the absence of disease progression or unacceptable toxicity. NOTE: \*For both regimens, dactinomycin is omitted during radiotherapy. NOTE: \*\*Clinical Group I tumors and those with Clinical Group III uterine/cervix primary disease with negative nodes who have undergone a complete resection (i.e. hysterectomy) at Week 13 do not receive radiotherapy at Week 13 Patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.390 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 49 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 163 locations
Phoenix Childrens Hospital
Phoenix, United StatesUniversity of Arizona Health Sciences Center
Tucson, United StatesUniversity of Arkansas for Medical Sciences
Little Rock, United States