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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/NCT00335556
Registration number
NCT00335556
Ethics application status
Date submitted
8/06/2006
Date registered
12/06/2006
Date last updated
21/07/2017
Titles & IDs
Public title
Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
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Scientific title
Treatment of High Risk Renal Tumors: A Groupwide Phase II Study
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Secondary ID [1]
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NCI-2009-00414
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Secondary ID [2]
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AREN0321
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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:
Childhood Renal Cell Carcinoma
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Clear Cell Renal Cell Carcinoma
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Clear Cell Sarcoma of the Kidney
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Papillary Renal Cell Carcinoma
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Rhabdoid Tumor of the Kidney
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Stage I Renal Cell Cancer
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Stage I Renal Wilms Tumor
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Stage II Renal Cell Cancer
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Stage II Renal Wilms Tumor
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Stage III Renal Cell Cancer
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Stage III Renal Wilms Tumor
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Stage IV Renal Cell Cancer
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Stage IV Renal Wilms Tumor
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Children's - Other
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Irinotecan Hydrochloride
Treatment: Surgery - Conventional Surgery
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Etoposide
Treatment: Drugs - Carboplatin
Other interventions - Dactinomycin
Treatment: Drugs - Vincristine Sulfate
Treatment: Other - Radiation Therapy
Other interventions - Laboratory Biomarker Analysis
Experimental: Surgery - Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician's choice.
Experimental: Treatment (UH-1) - Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, and carboplatin. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable clear cell sarcoma of the kidney (CCSK) receive no further study therapy.
Experimental: Treatment (window/UH-1) - Patients receive vincristine IV on days 1 and 8 and irinotecan hydrochloride IV over 30 minutes on days 1-5 and 8-12 (course 1). Patients with progressive disease (PD) are treated with regimen UH-1. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive another course of irinotecan hydrochloride/vincristine window therapy beginning on day 22. After the second course, patients with SD or PD are treated with regimen UH-1 and patients with PR or CR are treated with regimen UH-2.
Experimental: Treatment (UH-2) - Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, carboplatin, and irinotecan hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 7. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 7.
Experimental: Treatment (regimen I) - Patients receive vincristine, doxorubicin hydrochloride, cyclophosphamide, and etoposide. Patients whose primary tumors were initially resected (except those with stage I CCSK) undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.
Experimental: Treatment (regimen DD-4A) - Patients receive dactinomycin, vincristine, and doxorubicin hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV
Treatment: Drugs: Irinotecan Hydrochloride
Given IV
Treatment: Surgery: Conventional Surgery
Patients undergo resection
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Etoposide
Given IV
Treatment: Drugs: Carboplatin
Given IV
Other interventions: Dactinomycin
Given IV
Treatment: Drugs: Vincristine Sulfate
Given IV
Treatment: Other: Radiation Therapy
Undergo radiotherapy
Other interventions: Laboratory Biomarker Analysis
Correlative studies
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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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Intervention code [4]
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Treatment: Other
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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 of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)
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Assessment method [1]
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Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS-5 (NCT00002610).
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Timepoint [1]
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4 years
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Primary outcome [2]
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Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors
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Assessment method [2]
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The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).
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Timepoint [2]
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4 years
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Primary outcome [3]
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Response Rate
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Assessment method [3]
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Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non-index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.
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Timepoint [3]
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Up to 2 months
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Primary outcome [4]
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Event Free Survival Probability
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Assessment method [4]
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Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).
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Timepoint [4]
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4 years
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Primary outcome [5]
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Toxicity Rate
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Assessment method [5]
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Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.
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Timepoint [5]
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Up to 4 years
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Secondary outcome [1]
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Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Frequency of TP53 Mutations
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Assessment method [2]
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Timepoint [2]
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At baseline
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Eligibility
Key inclusion criteria
- Newly diagnosed disease of 1 of the following histologic types:
- Focal anaplastic Wilms' tumor
- Diffuse anaplastic Wilms' tumor
- Clear cell sarcoma of the kidney
- Malignant rhabdoid tumor (renal or extrarenal)
- Renal cell carcinoma
- Clear cell
- Papillary
- Renal medullary
- Oncocytoid
- Sarcomatoid
- Chromophobe
- Translocation
- Collecting duct
- Carcinoma associated with neuroblastoma
- Renal cell carcinoma unclassified
- Specimens/materials must be submitted for central review by Day 7
- Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy
(surgery/biopsy is Day 0), unless medically contraindicated
- Karnofsky performance status (PS) must be >= 50 for patients > 16 years if age and
Lansky PS must be >= 50 for patients =< 16 years of age
- Patients must not have received systemic chemotherapy or radiation therapy prior to
treatment on this study UNLESS they were enrolled on the AREN0532 or AREN0533 studies
and received prenephrectomy chemotherapy for what was originally presumed to be
favorable histology Wilms tumor; additionally, patients with pediatric RCC who
previously received chemotherapy for another type of malignancy (not the RCC) or
non-malignant condition may enroll on the study
- Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST] or
serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ ALT]) < 2.5
times ULN for age
- Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by
radionuclide angiogram
- Female patients of childbearing age must have a negative pregnancy test
- Female patients who are lactating must agree to stop breast-feeding
- Sexually active patients of childbearing potential must agree to use effective
contraception
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
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Minimum age
No limit
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Maximum age
29
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 2
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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
1/06/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
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Sample size
Target
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Accrual to date
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Final
291
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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John Hunter Children's Hospital - Hunter Regional Mail Centre
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Recruitment hospital [2]
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Sydney Children's Hospital - Randwick
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The Children's Hospital at Westmead - Westmead
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Royal Brisbane and Women's Hospital - Herston
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Royal Children's Hospital-Brisbane - Herston
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Women's and Children's Hospital-Adelaide - North Adelaide
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Recruitment hospital [7]
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Royal Children's Hospital - Parkville
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Recruitment hospital [8]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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2310 - Hunter Regional Mail Centre
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment postcode(s) [5]
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5006 - North Adelaide
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Recruitment postcode(s) [6]
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3052 - Parkville
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Recruitment postcode(s) [7]
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6008 - Perth
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Recruitment outside Australia
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Alabama
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San Juan
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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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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or
surgery work in treating patients with high-risk kidney tumors. 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. Giving more than one drug (combination chemotherapy) may kill
more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
combination chemotherapy together with radiation therapy before surgery may make the tumor
smaller and reduce the amount of normal tissue that needs to be removed.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00335556
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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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Jeffrey Dome, MD
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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/NCT00335556
Download to PDF