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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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17 October 2012 |
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Main ID: |
NCT00304070 |
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Date of registration:
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15/03/2006 |
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Primary sponsor: |
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Public title:
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Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
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Scientific title:
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Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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79 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00304070 |
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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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Brazil
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Canada
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United States
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Contacts
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Name:
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Carlos Rodriguez-Galindo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dana-Farber Cancer Institute |
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Name:
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Raul C. Ribeiro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Jude Children's Research Hospital |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed adrenocortical carcinoma
- Newly diagnosed disease within the past 3 weeks
- Any disease stage allowed
PATIENT CHARACTERISTICS:
- Lansky performance status 60-100% (for patients = 16 years old)
- Karnofsky performance status 60-100% (for patients > 16 years old)
- Absolute neutrophil count = 750/mm^3
- Platelet count = 75,000/mm^3
- Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min OR serum
creatinine based on age as follows:
- 0.4 mg/dL (1 month to < 6 months)
- 0.5 mg/dL (6 months to < 1 year of age)
- 0.6 mg/dL (1 to < 2 years of age
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 mg/dL (male) or 1.4 mg/dL (female) (= 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:
- No previous chemotherapy for adrenocortical carcinoma
Age minimum:
N/A
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adrenocortical Carcinoma
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Intervention(s)
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Biological: filgrastim
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Biological: pegfilgrastim
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Drug: cisplatin
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Drug: doxorubicin hydrochloride
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Drug: etoposide
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Drug: mitotane
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Procedure: conventional surgery
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Primary Outcome(s)
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Measurable metastatic disease
[Time Frame: No]
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Nonmeasurable metastatic disease
[Time Frame: No]
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Overall response
[Time Frame: No]
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Primary tumor measurement
[Time Frame: No]
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Response of metastatic target lesions
[Time Frame: No]
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Secondary ID(s)
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CDR0000467191
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COG-ARAR0332
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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