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View Clinical Trial (Medical Research Study)
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Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma - NCT00245141-Toyama - 0016 (Clinical Trial 132644)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy132644.aspx
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Toyama |
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Country:
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Japan |
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| Conditions: |
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Sarcoma |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and
cyclophosphamide, 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 more than one drug (combination chemotherapy) with
radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and
cyclophosphamide together with or without radiation therapy works in treating patients with
embryonal rhabdomyosarcoma.
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| Study summary: |
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OBJECTIVES:
- Determine the progression-free survival rate in patients with low-risk embryonal
rhadomyosarcoma treated with a shortened treatment schedule of vincristine,
dactinomycin, and cyclophosphamide with or without radiotherapy.
OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients
may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of
24 weeks) in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of embryonal rhabdomyosarcoma
- Primary operation for pathological diagnosis within the past 42 days
- The following variants are eligible:
- Botryoid
- Spindle cell
- Anaplastic
- Meets 1 of the following stage criteria:
- Stage I, clinical group I or II (N0), defined by all of the following criteria:
- Favorable site, including orbit, head, and neck (excluding parameningeal
sites), genitourinary region (excluding bladder/prostate sites), or biliary
tract
- Tumor any size
- Completely resected disease OR microscopic residual disease
- Lymph nodes clinically negative
- Stage I, clinical group III (N0), defined by all of the following criteria:
- Favorable site
- Tumor any size
- Gross residual disease allowed (orbit only)
- Lymph nodes clinically negative
- Stage II, clinical group I (N0, Nx), defined by all of the following criteria:
- Unfavorable site (any sites not listed as favorable sites)
- Tumor ≤ 5 cm in diameter
- Completely resected disease
- Lymph nodes clinically negative OR lymph node involvement unknown
PATIENT CHARACTERISTICS:
Performance status
- 0-3
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 7.5 g/dL
Hepatic
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
- Bile acid ≤ 2.5 times ULN
Renal
- Creatinine based on age as follows:
- < 0.8 mg/dL (for patients < 5 years of age)
- < 1.2 mg/dL (for patients 5-9 years of age)
- < 1.5 mg/dL (for patients ≥ 10 years of age)
Cardiovascular
- No severe heart disease
Other
- Not pregnant or nursing
- Must have acceptable organ function for age
- No uncontrolled infection
- No other active malignancy
- No other treated malignancy within the past 5 years
- No hypersensitivity to study drugs
- No Charcot-Marie-Tooth disease
- No chickenpox
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior anticancer chemotherapy
Endocrine therapy
- Prior anticancer steroids allowed
Radiotherapy
- No prior radiotherapy
Other
- No concurrent pentostatin |
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| Study is available at: |
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Toyama University Hospital
Toyama
Japan
Primary Contact:
Hirokazu Kanegane
Email: kanegane@ms.toyama-mpu.ac.jp
Phone: 81-76-434-7313 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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