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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 October 2012 |
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Main ID: |
NCT00379340 |
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Date of registration:
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19/09/2006 |
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Primary sponsor: |
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Public title:
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Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms Tumor
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Scientific title:
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Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00379340 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Canada
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Israel
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New Zealand
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Puerto Rico
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Switzerland
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United States
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Contacts
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Name:
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David B. Dix, MD, FRCP, MBChB |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's and Women's Hospital of British Columbia |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Newly diagnosed Wilms tumor meeting 1 of the following criteria:
- Stage IV disease with favorable histology with or without loss of heterozygosity
(LOH) for 1p and 16q
- Stage III disease with favorable histology with LOH for 1p and 16q transferring
from clinical trial COG-AREN0532
- Patients must begin therapy within 14 days after surgery or biopsy (day 0), unless
medically contraindicated
- Extra-pulmonary metastases include lymph node involvement in the hilum and/or
mediastinum deemed by the treating institution to represent malignant disease, or
positive cytology-proven pleural effusions
- No bilateral Wilms tumors (stage IV)
- Patients should be referred to COG-AREN0534
- Previously enrolled in clinical trial COG-AREN03B2
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky
PS 50-100% (for patients = 16 years of age)
- Bilirubin = 1.5 times upper limit of normal (ULN)
- AST or ALT < 2.5 times ULN
- Shortening fraction = 27% by echocardiogram OR ejection fraction = 50% by
radionuclide angiogram
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior tumor-directed chemotherapy or radiotherapy unless transferring from
clinical trial COG-AREN0532 OR treatment for emergent issues, as medically indicated
- No concurrent aprepitant
Age minimum:
N/A
Age maximum:
29 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Cancer
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Metastatic Cancer
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Intervention(s)
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Biological: dactinomycin
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Drug: cyclophosphamide
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Drug: doxorubicin hydrochloride
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Drug: etoposide
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Drug: vincristine sulfate
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Procedure: therapeutic conventional surgery
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Radiation: radiation therapy
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Primary Outcome(s)
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Event-free survival as measured by Woolson and an O'Brien-Fleming Boundary at 4 years
[Time Frame: No]
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Secondary ID(s)
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CDR0000496508
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COG-AREN0533
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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