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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00304070
Registration number
NCT00304070
Ethics application status
Date submitted
15/03/2006
Date registered
17/03/2006
Date last updated
28/02/2024
Titles & IDs
Public title
Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
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Scientific title
Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study
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Secondary ID [1]
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NCI-2009-00413
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Secondary ID [2]
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ARAR0332
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stage I Adrenal Cortical Carcinoma AJCC v7
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Stage II Adrenal Cortical Carcinoma AJCC v7
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0
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Stage III Adrenal Cortical Carcinoma AJCC v7
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Stage IV Adrenal Cortical Carcinoma AJCC v7
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Condition category
Condition code
Cancer
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0
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Non melanoma skin cancer
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Cancer
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0
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Kidney
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Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cisplatin
Treatment: Surgery - Conventional Surgery
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Etoposide
Other interventions - Filgrastim
Treatment: Drugs - Mitotane
Other interventions - Pegfilgrastim
Experimental: Stratum I (surgery, observation) - Patients undergo primary tumor resection and retroperitoneal lymph node sampling followed by observation. Patients who have undergone prior surgery without nodal sampling undergo observation only.
Experimental: Stratum II (exploratory surgery, observation) - Patients undergo primary tumor resection and extended regional lymph node dissection followed by observation. Patients who have undergone prior surgery with simple resection of the primary tumor undergo exploratory surgery with extended regional lymph node dissection followed by observation.
Experimental: Stratum III (chemotherapy, surgery) - Patients receive combination chemotherapy with filgrastim (G-CSF) for up to 30 weeks (10 courses) followed by mitotane alone for an additional 2 months. Some patients undergo surgery after chemotherapy course 2 or 4. Some patients undergo additional surgery after finishing all chemotherapy.
Treatment: Drugs: Cisplatin
Given IV
Treatment: Surgery: Conventional Surgery
Patients undergo surgery
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV
Treatment: Drugs: Etoposide
Given IV
Other interventions: Filgrastim
Given subcutaneously
Treatment: Drugs: Mitotane
Given orally
Other interventions: Pegfilgrastim
Given subcutaneously
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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Intervention code [3]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Five Year Event-free Survival (EFS)
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Assessment method [1]
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The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.
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Timepoint [1]
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Up to five years after enrollment
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Secondary outcome [1]
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Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
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Assessment method [1]
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The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy
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Timepoint [1]
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Up to 182 Days After Enrollment
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Secondary outcome [2]
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Complications Associated With Radical Adrenalectomy and RLND
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Assessment method [2]
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Any patient who dies because of surgery or has a grade 3 or 4 toxicity possibly, probably or likely related to surgery will be considered as having experienced a surgical complication. The complication rate is estimated as the proportion of evaluable patients that have a complication.
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Timepoint [2]
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Up to 1 month after surgery
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Secondary outcome [3]
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Frequency of Lymph Node Involvement by Imaging.
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Assessment method [3]
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The number eligible patients who have lymph node involvement by imaging at study enrollment.
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Timepoint [3]
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At study enrollment
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Secondary outcome [4]
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Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.
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Assessment method [4]
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The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group.
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Timepoint [4]
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At study enrollment
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Secondary outcome [5]
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Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.
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Assessment method [5]
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The number of eligible patients who have A43 del33bp mutation of (beta)-catenin.
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Timepoint [5]
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Patients who had surgery at time of enrollment.
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Secondary outcome [6]
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Frequency of Tumor Spillage at the Time of Tumor Resection
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Assessment method [6]
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The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection.
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Timepoint [6]
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Up to one year or while on protocol therapy, whichever is less
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Eligibility
Key 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:
- 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
- No previous chemotherapy for adrenocortical carcinoma
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Minimum age
No limit
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/05/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2023
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Sample size
Target
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Accrual to date
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Final
78
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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6008 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Wisconsin
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Brazil
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San Paulo
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Brazil
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Sao Paulo
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Canada
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Alberta
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Ontario
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Ethics approval
Ethics application status
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Summary
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. Drugs used in chemotherapy, such as cisplatin, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal
tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain
after surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00304070
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Carlos Rodriguez-Galindo
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Address
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Children's Oncology Group
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00304070
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