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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00379340




Trial ID
NCT00379340
Ethics application status
Date submitted
19/09/2006
Date registered
19/09/2006
Date last updated
17/05/2017

Titles & IDs
Public title
Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
Scientific title
Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors
Secondary ID [1] 0 0
NCI-2009-00419
Secondary ID [2] 0 0
AREN0533
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage III Wilms Tumor With Loss of Heterozygosity (LOH) for 1p and 16q 0 0
Stage IV Wilms Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - liposomal vincristine sulfate
Treatment: Surgery - conventional surgery
Treatment: Other - 3-dimensional conformal radiation therapy
Other interventions - dactinomycin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide

Experimental: Stage IV and rapid complete response (RCR) of lung metastases - Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A

Experimental: Stage IV and slow incomplete response (SIR) of lung metastases - Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A

Other: Stage III/IV with LOH 1p and 16q treated with Regimen M - Stage III/IV with LOH 1p and 16q treated with Regimen M

Other: Stage IV with non-lung disease treated with Regimen M - Stage IV with non-lung disease treated with Regimen M

Other: Stage IV with lung metastases - Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6


Treatment: Drugs: doxorubicin hydrochloride
Given IV

Treatment: Drugs: liposomal vincristine sulfate
Given IV

Treatment: Surgery: conventional surgery


Treatment: Other: 3-dimensional conformal radiation therapy


Other interventions: dactinomycin
Given IV

Treatment: Drugs: cyclophosphamide
Given IV

Treatment: Drugs: etoposide
Given IV

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Intervention code [3] 0 0
Treatment: Other
Intervention code [4] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival Probability - Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Timepoint [1] 0 0
4 years
Primary outcome [2] 0 0
Event Free Survival (EFS) Probability - Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Timepoint [2] 0 0
At 4 years
Primary outcome [3] 0 0
Event Free Survival Probability - Probability of no relapse, secondary malignancy, or death after 4 year in the study
Timepoint [3] 0 0
At 4 years
Secondary outcome [1] 0 0
Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease - Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Timepoint [1] 0 0
At 4 years

Eligibility
Key inclusion criteria
- 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, unless medically
contraindicated

- No bilateral Wilms' tumors (stage IV)

- Patients should be referred to COG-AREN0534

- Previously enrolled in clinical trial COG-AREN03B2

- 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

- 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
Minimum age
No limit
Maximum age
29 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Royal Childrens Hospital - Herston
Recruitment hospital [5] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [7] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
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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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Nebraska
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New Hampshire
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Vermont
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Israel
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Tikua
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Auckland
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Puerto Rico
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Santurce
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Switzerland
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Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This phase III trial is studying how well combination chemotherapy with or without radiation
therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable
Histology Wilms' tumor. Drugs used in chemotherapy 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 or without radiation therapy may kill more tumor cells.
Trial website
https://clinicaltrials.gov/show/NCT00379340
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Dix, MD
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries