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Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor

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ClinicalTrials.gov Identifier: NCT00352534
Recruitment Status : Completed
First Posted : July 14, 2006
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage I Wilms Tumor
Stage II Wilms Tumor
Stage III Wilms Tumor
Interventions Procedure: therapeutic conventional surgery
Drug: vincristine sulfate
Biological: dactinomycin
Drug: doxorubicin hydrochloride
Radiation: 3-dimensional conformal radiation therapy
Enrollment 808
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stage I/II Stage III Very Low Risk Disease Low Risk, Stage I or II, no LOH Standard Risk, Stage I or II With LOH Standard Risk, Stage III High Risk
Hide Arm/Group Description Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment. Treatment arm. Nephrectomy and re-evaluation,very low-risk disease. Treatment arm. Low risk, stage I or II, no loss of heterozygosity (LOH). Treatment arm. Standard Risk, Stage I or II with LOH. Treatment arm. Standard Risk, Stage III. Treatment arm. High risk.
Period Title: Initial Staging
Started 211 597 0 0 0 0 0
Completed 203 588 0 0 0 0 0
Not Completed 8 9 0 0 0 0 0
Reason Not Completed
Ineligible             8             9             0             0             0             0             0
Period Title: Final Risk Group Assignment
Started 0 0 119 52 32 548 40
Completed 0 0 116 49 31 503 1
Not Completed 0 0 3 3 1 45 39
Reason Not Completed
Lack of Efficacy             0             0             0             2             1             19             0
Physician Decision             0             0             0             0             0             8             0
Withdrawal by Subject             0             0             0             0             0             3             0
Ineligible             0             0             3             1             0             13             0
Enrollment onto another COG study             0             0             0             0             0             0             28
Stage III Wilms tumor with LOH             0             0             0             0             0             0             11
Death             0             0             0             0             0             2             0
Arm/Group Title Stage I or II Stage III Total
Hide Arm/Group Description Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment. Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment. Total of all reporting groups
Overall Number of Baseline Participants 211 597 808
Hide Baseline Analysis Population Description
Stage I or II: Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment. Stage III: Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 211 participants 597 participants 808 participants
23.91  (24.37) 50.62  (30.89) 43.64  (31.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 597 participants 808 participants
Female
110
  52.1%
318
  53.3%
428
  53.0%
Male
101
  47.9%
279
  46.7%
380
  47.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 597 participants 808 participants
Hispanic or Latino
38
  18.0%
89
  14.9%
127
  15.7%
Not Hispanic or Latino
165
  78.2%
482
  80.7%
647
  80.1%
Unknown or Not Reported
8
   3.8%
26
   4.4%
34
   4.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 597 participants 808 participants
American Indian or Alaska Native
1
   0.5%
6
   1.0%
7
   0.9%
Asian
2
   0.9%
15
   2.5%
17
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
39
  18.5%
89
  14.9%
128
  15.8%
White
141
  66.8%
417
  69.8%
558
  69.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
28
  13.3%
70
  11.7%
98
  12.1%
1.Primary Outcome
Title Event Free Survival Probability
Hide Description Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible very low risk or standard risk patients
Arm/Group Title Very Low Risk Standard Risk, Stage I or II, With LOH Standard Risk, Stage III
Hide Arm/Group Description:
Very Low Risk
Standard Risk, Stage I or II, with LOH
Standard Risk, Stage III
Overall Number of Participants Analyzed 116 32 535
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.88
(0.79 to 0.98)
0.87
(0.73 to 1.00)
0.88
(0.85 to 0.91)
2.Primary Outcome
Title Overall Survival (OS) Probability
Hide Description Probability of being alive after 4 years in the study.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible very low risk or standard risk patients
Arm/Group Title Very Low Risk Standard Risk, Stage I or II, With LOH Standard Risk, Stage III
Hide Arm/Group Description:
Very Low Risk
Standard Risk, Stage I or II, with LOH
Standard Risk, Stage III
Overall Number of Participants Analyzed 116 32 535
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
1.00
(1 to 1)
1.00
(1 to 1)
0.97
(0.95 to 0.99)
3.Secondary Outcome
Title Incidence of Contralateral Kidney Lesions
Hide Description Number of contralateral kidney lesions during follow-up.
Time Frame During follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Very low risk patients treated by nephrectomy and observation only.
Arm/Group Title Very Low Risk
Hide Arm/Group Description:
Very Low Risk
Overall Number of Participants Analyzed 116
Measure Type: Number
Unit of Measure: Lesions
1
4.Secondary Outcome
Title Incidence of Renal Failure
Hide Description Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up
Time Frame During follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Very low risk patients that have metachronous relapse.
Arm/Group Title Very Low Risk
Hide Arm/Group Description:
Very Low Risk
Overall Number of Participants Analyzed 116
Measure Type: Number
Unit of Measure: Incidents
0
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events were reported for eligible patients only.
 
Arm/Group Title Very Low Risk Disease Low Risk, Stage I or II, no LOH Standard Risk, Stage I or II, With LOH Standard Risk, Stage III High Risk
Hide Arm/Group Description Nephrectomy and Re-evaluation Low risk, stage I or II, no loss of heterozygosity (LOH). Standard Risk, Stage I or II, with loss of heterozygosity (LOH). Nephrectomy/Biopsy, Chemotherapy High risk.
All-Cause Mortality
Very Low Risk Disease Low Risk, Stage I or II, no LOH Standard Risk, Stage I or II, With LOH Standard Risk, Stage III High Risk
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Very Low Risk Disease Low Risk, Stage I or II, no LOH Standard Risk, Stage I or II, With LOH Standard Risk, Stage III High Risk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/116 (0.00%)      0/51 (0.00%)      0/32 (0.00%)      20/535 (3.74%)      1/40 (2.50%)    
Gastrointestinal disorders           
36700-Gastrointestinal disorders - Other specify  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
75700-Small intestinal obstruction  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
General disorders           
24600-Death NOS  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 10/535 (1.87%)  10 0/40 (0.00%)  0
37200-General disorders and administration site conditions  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
55700-Multi-organ failure  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
Hepatobiliary disorders           
40000-Hepatic failure  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
Infections and infestations           
73700-Sepsis  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 2/535 (0.37%)  3 0/40 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
51900-Leukemia secondary to oncology chemotherapy  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
58000-Neoplasms benign malignant and unspecified (incl cy  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 3/535 (0.56%)  3 1/40 (2.50%)  1
Nervous system disorders           
73600-Seizure  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
1
Term from vocabulary, CTCv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Very Low Risk Disease Low Risk, Stage I or II, no LOH Standard Risk, Stage I or II, With LOH Standard Risk, Stage III High Risk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/116 (0.00%)      2/51 (3.92%)      0/32 (0.00%)      31/535 (5.79%)      0/40 (0.00%)    
Blood and lymphatic system disorders           
33300-Febrile neutropenia  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
Gastrointestinal disorders           
14900-Ascites  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 2/535 (0.37%)  2 0/40 (0.00%)  0
36400-Gastritis  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
75700-Small intestinal obstruction  0/116 (0.00%)  0 1/51 (1.96%)  1 0/32 (0.00%)  0 0/535 (0.00%)  0 0/40 (0.00%)  0
87900-Vomiting  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
General disorders           
33900-Fever  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
Hepatobiliary disorders           
40600-Hepatobiliary disorders - Other specify  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
Infections and infestations           
44800-Infections and infestations - Other specify  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 2/535 (0.37%)  4 0/40 (0.00%)  0
73700-Sepsis  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
Injury, poisoning and procedural complications           
47000-Intraoperative gastrointestinal injury  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
66800-Postoperative hemorrhage  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
Investigations           
11600-Alanine aminotransferase increased  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 5/535 (0.93%)  6 0/40 (0.00%)  0
15000-Aspartate aminotransferase increased  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 6/535 (1.12%)  6 0/40 (0.00%)  0
58300-Neutrophil count decreased  0/116 (0.00%)  0 1/51 (1.96%)  1 0/32 (0.00%)  0 7/535 (1.31%)  9 0/40 (0.00%)  0
Metabolism and nutrition disorders           
41400-Hyperglycemia  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  2 0/40 (0.00%)  0
41600-Hyperkalemia  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
42500-Hyperuricemia  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 2/535 (0.37%)  2 0/40 (0.00%)  0
42700-Hypocalcemia  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
42900-Hypoglycemia  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 2/535 (0.37%)  2 0/40 (0.00%)  0
43100-Hypokalemia  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 7/535 (1.31%)  8 0/40 (0.00%)  0
Renal and urinary disorders           
71300-Renal hemorrhage  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
71500-Respiratory failure  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 2/535 (0.37%)  2 0/40 (0.00%)  0
71600-Respiratory thoracic and mediastinal disorders - Ot  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
Vascular disorders           
43600-Hypotension  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 1/535 (0.19%)  1 0/40 (0.00%)  0
79600-Thromboembolic event  0/116 (0.00%)  0 0/51 (0.00%)  0 0/32 (0.00%)  0 2/535 (0.37%)  2 0/40 (0.00%)  0
1
Term from vocabulary, CTCv4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00352534     History of Changes
Other Study ID Numbers: AREN0532
NCI-2009-01067 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000487540 ( Other Identifier: ClinicalTrials.gov )
AREN0532 ( Other Identifier: Children's Oncology Group )
AREN0532 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: July 13, 2006
First Posted: July 14, 2006
Results First Submitted: October 26, 2016
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017