Status:
COMPLETED
Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage I Adrenal Cortical Carcinoma AJCC v7
Stage II Adrenal Cortical Carcinoma AJCC v7
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
Brief Summary
This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with stage I, stage II, stage III or stage IV adrenocortical cancer. Dru...
Detailed Description
PRIMARY OBJECTIVES: I. Describe the outcome of patients with stage I adrenocortical tumor (ACT) treated with surgery alone. II. Describe the outcome of patients with stage II ACT treated with radica...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed adrenocortical carcinoma
- Newly diagnosed disease within the past 3 weeks
- Any disease stage allowed
- 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:
- 4 mg/dL (1 month to \< 6 months)
- 5 mg/dL (6 months to \< 1 year of age)
- 6 mg/dL (1 to \< 2 years of age
- 8 mg/dL (2 to \< 6 years of age)
- 0 mg/dL (6 to \< 10 years of age)
- 2 mg/dL (10 to \< 13 years of age)
- 5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
- 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
- No previous chemotherapy for adrenocortical carcinoma
Exclusion
Key Trial Info
Start Date :
May 3 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00304070
Start Date
May 3 2007
End Date
June 30 2023
Last Update
February 28 2024
Active Locations (91)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205