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Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma Clinical research trials and Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma. Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma  Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
For Condition: embryonal-botryoid childhood rhabdomyosarcoma,embryonal childhood rhabdomyosarcoma,previously untreated childhood rhabdomyosarcoma,adult soft tissue sarcoma
Status: Not yet recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed low-risk rhabdomyosarcoma.
Details: OBJECTIVES: Primary - Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine, dactinomycin, cyclophosphamide, and radiotherapy. Secondary - Determine local control rates in patients treated with this regimen. - 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. - 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): 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 30-60 minutes 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): 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, administered as in regimen I, and continued VA* chemotherapy as in regimen I or II. In both regimens, treatment continues in the absence of disease progression or unacceptable toxicity. NOTE: *For both regimens, dactinomycin is omitted during radiotherapy. NOTE: **Patients with clinical group I disease or completely resected node-negative clinical group III uterine/cervix primary disease do not receive radiotherapy. Patients with node-negative vaginal primary disease receive radiotherapy beginning on week 25, if necessary. Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 360 patients (260 for regimen I [subset 1] and 100 for regimen II [subset 2]) will be accrued for this study within 6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /49 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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: - 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: - 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) - 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 PATIENT CHARACTERISTICS: Age - Under 50 - No infants who would not be able to receive study radiotherapy, in the opinion of the treating physician Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 750/mm^3 - Platelet count at least 75,000/mm^3 (transfusion independent) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN)* - AST or ALT no greater than 2.5 times ULN NOTE: *Patients with primary hepatic or biliary tumors and bilirubin greater than 1.5 times ULN allowed provided all other eligibility criteria are met Renal - Creatinine* based on age 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 10 - No greater than 1.2 mg/dL for patients age 11 to 15 - No greater than 1.5 mg/dL for patients over age 15 OR - Creatinine clearance* or radioisotope glomerular filtration rate at least 70 mL/min NOTE: *Patients with tumors obstructing the urinary tract causing elevated creatinine allowed provided all other eligibility criteria are met Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy (except for patients treated on the related intermediate-risk study) Endocrine therapy - Prior steroids allowed Radiotherapy - No prior radiotherapy Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidWalterhouse, Study Chair, Children's Memorial Hospital, Chicago
Additional Information:
Study ID Numbers: CDR0000347078; COG-ARST0331
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075582
Other Previously Untreated Childhood Rhabdomyosarcoma Studies:
1. Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma
2. Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
3. Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
Related Studies:
Other previously untreated childhood rhabdomyosarcoma Clinical Trials
Other Clinical Trials
Other Clinical Trials
Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
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