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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00002610
Registration number
NCT00002610
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
25/07/2014
Titles & IDs
Public title
Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors
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Scientific title
National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study
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Secondary ID [1]
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COG-Q9402
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Secondary ID [2]
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9444
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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:
Kidney Cancer
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Condition category
Condition code
Cancer
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Kidney
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Cancer
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Children's - Other
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - vincristine sulfate
Experimental: STRATUM A - Treatment of children in Stratum A will be determined by the site of relapse and the presence of microscopic or gross residual disease after attempted surgical excision of the relapse.
Experimental: Stratum B - All children who received combination chemotherapy with Regimen EE - 4A as their initial therapy for Wilms tumor will receive Regimen I and radiation therapy to the site of recurrence. All patients will receive prophylactic trimethoprim /sulfamethoxazole
Experimental: STRATUM C - All children who received combination chemotherapy with Regimen DD - 4A as their initial therapy for Wilms tumor will be treated with the following chemotherapy. All patients will receive prophylactic trimethoprim/sulfamethoxazole
Experimental: STRATUM D - Six week cycles of chemotherapy will be given to all patients who do not have progressive disease at the time of each week 0 re-evaluation.
Treatment: Drugs: vincristine sulfate
IV
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Intervention code [1]
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Treatment: Drugs
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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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Event free survival
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Assessment method [1]
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To determine the two-year second event-free survival percentage for children who relapse following initial therapy with nephrectomy only following treatment with vincristine and dactinomycin, with or without doxorubicin, depending upon the site of relapse and presence or absence of microscopic residual disease.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Event Free Survival
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Assessment method [1]
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To determine if the two-year second event-free survival percentage for children who relapse following initial treatment with Regimen EE-4A who do not have loss of heterozygosity of markers for chromosome 16q, 1p or increased DNA content in tumor cells is not less than 40% higher than that of similar patients who have loss of heterozygosity for chromosome 16q, 1p or increased DNA content following treatment with intensive chemotherapy using doxorubicin, etoposide, cyclophosphamide and carboplatin, and radiation therapy to sites of microscopic or gross residual disease.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Post-relapse survival
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Assessment method [2]
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To determine if the four-year post-relapse survival percentage for children who relapse following initial treatment with Regimen DD - 4A who do not have loss of heterozygosity of markers for chromosome 16q, 1p or increased DNA content in tumor cells is not less than 40% higher than that of similar patients who have loss of heterozygosity for chromosome 16q, 1p or increased DNA content following treatment with intensive chemotherapy using etoposide, cyclophosphamide and carboplatin.
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Timepoint [2]
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4 years
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Secondary outcome [3]
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Response rate
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Assessment method [3]
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To determine if the response rate (CR + PR) of clear cell sarcoma of the kidney and diffuse anaplastic Wilms tumor to the combination of carboplatin and etoposide each exceed 20%.
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Timepoint [3]
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Diagnosis of Wilms' tumor
* Eligible subtypes:
* Favorable histologies
* Anaplastic histologies
* Clear cell sarcoma of the kidney
* Rhabdoid tumor of the kidney
* Relapsed disease after entry on protocol NWTS-5 (NWTS-Q9401)
PATIENT CHARACTERISTICS:
Age:
* 21 and under at original diagnosis
Performance status:
* Not specified
Life expectancy:
* At least 4 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm^3
* Platelet count at least 100,000/mm^3
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT or SGPT less than 2.5 times normal
Renal:
* Creatinine no greater than 1.5 times normal OR
* Creatinine clearance or GFR at least 70 mL/min
Cardiovascular:
* Shortening fraction at least 27% by echocardiogram OR
* Ejection fraction greater than 50% by echocardiogram or MUGA scan
Other:
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 2 weeks since prior chemotherapy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior therapy for relapsed Wilms' tumor
* Recovered from the toxic effects of any other prior therapy
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Minimum age
No limit
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Maximum age
21
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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
Blinded (masking used)
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Who is / are masked / blinded?
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Phase
Phase 3
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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
1/01/1996
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Date of last participant enrolment
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Date of last data collection
Anticipated
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Actual
1/02/2006
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Sample size
Target
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Accrual to date
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Final
203
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Sydney Children's Hospital - Randwick
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Children's Hospital at Westmead - Westmead
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Royal Children's Hospital - Brisbane
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Women's and Children's Hospital - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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2031 - Randwick
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2145 - Westmead
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4029 - Brisbane
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5006 - North Adelaide
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3052 - Parkville
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
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Trial website
https://clinicaltrials.gov/study/NCT00002610
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Trial related presentations / publications
Kalapurakal JA, Perlman EJ, Seibel NL, Ritchey M, Dome JS, Grundy PE. Outcomes of patients with revised stage I clear cell sarcoma of kidney treated in National Wilms Tumor Studies 1-5. Int J Radiat Oncol Biol Phys. 2013 Feb 1;85(2):428-31. doi: 10.1016/j.ijrobp.2012.04.023. Epub 2012 Jun 1. Green DM, Cotton CA, Malogolowkin M, Breslow NE, Perlman E, Miser J, Ritchey ML, Thomas PR, Grundy PE, D'Angio GJ, Beckwith JB, Shamberger RC, Haase GM, Donaldson M, Weetman R, Coppes MJ, Shearer P, Coccia P, Kletzel M, Macklis R, Tomlinson G, Huff V, Newbury R, Weeks D. Treatment of Wilms tumor relapsing after initial treatment with vincristine and actinomycin D: a report from the National Wilms Tumor Study Group. Pediatr Blood Cancer. 2007 May;48(5):493-9. doi: 10.1002/pbc.20822. Ehrlich PF, Anderson JR, Ritchey ML, Dome JS, Green DM, Grundy PE, Perlman EJ, Kalapurakal JA, Breslow NE, Shamberger RC. Clinicopathologic findings predictive of relapse in children with stage III favorable-histology Wilms tumor. J Clin Oncol. 2013 Mar 20;31(9):1196-201. doi: 10.1200/JCO.2011.41.1165. Epub 2013 Feb 4.
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Public notes
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Contacts
Principal investigator
Name
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Daniel M. Green, MD
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Address
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Roswell Park Cancer Institute
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Green DM, Cotton CA, Malogolowkin M, Breslow NE, P...
[
More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT00002610
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