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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/NCT00379340




Registration number
NCT00379340
Ethics application status
Date submitted
19/09/2006
Date registered
21/09/2006
Date last updated
16/04/2024

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 Kidney Wilms Tumor 0 0
Stage IV Kidney 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: Other - 3-Dimensional Conformal Radiation Therapy
Treatment: Surgery - Conventional Surgery
Treatment: Drugs - Cyclophosphamide
Other interventions - Dactinomycin
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Etoposide
Treatment: Drugs - Vincristine Sulfate Liposome

Experimental: Treatment (chemotherapy, surgery, radiotherapy) - REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV. Patients with pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy.
Patients with initially unresectable or incompletely resected tumors are reevaluated at week 6, and if resectable, undergo surgery and then proceed to either regimen DD4A or regimen M.
REGIMEN DD4A (weeks 7-25): Patients receive dactinomycin IV; vincristine IV; and doxorubicin hydrochloride IV.
REGIMEN M (weeks 7-31): Patients receive cyclophosphamide IV; vincristine IV; and dactinomycin IV and doxorubicin hydrochloride IV. Patients with pulmonary metastases only who are SIR also undergo whole lung radiotherapy.


Treatment: Other: 3-Dimensional Conformal Radiation Therapy


Treatment: Surgery: Conventional Surgery


Treatment: Drugs: Cyclophosphamide
Given IV

Other interventions: Dactinomycin
Given IV

Treatment: Drugs: Doxorubicin Hydrochloride
Given IV

Treatment: Drugs: Etoposide
Given IV

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

Outcomes
Primary outcome [1] 0 0
Event Free Survival Probability
Timepoint [1] 0 0
4 years
Primary outcome [2] 0 0
Event Free Survival (EFS) Probability
Timepoint [2] 0 0
At 4 years
Primary outcome [3] 0 0
Event Free Survival Probability
Timepoint [3] 0 0
At 4 years
Secondary outcome [1] 0 0
Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
395
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 - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [5] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [6] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [7] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [8] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
6008 - Perth
Recruitment outside Australia
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Alabama
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Arizona
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Connecticut
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Delaware
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District of Columbia
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Illinois
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Oregon
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Pennsylvania
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Rhode Island
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Auckland
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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 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/ct2/show/NCT00379340
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David B Dix
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00379340