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Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00379340
Recruitment Status : Completed
First Posted : September 21, 2006
Results First Posted : June 14, 2017
Last Update Posted : September 17, 2019
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 III Wilms Tumor With Loss of Heterozygosity (LOH) for 1p and 16q
Stage IV Wilms Tumor
Interventions Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Procedure: conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Biological: dactinomycin
Drug: cyclophosphamide
Drug: etoposide
Enrollment 395
Recruitment Details  
Pre-assignment Details The 15 discrepant patients were ineligible to the study. They were excluded in the Participant Flow table because none of them were treated by the protocol and their group designations were unknown.
Arm/Group Title Stage IV and Rapid Complete Response (RCR) of Lung Metastases Stage IV and Slow Incomplete Response (SIR) of Lung Metastases Stage III/IV With LOH 1p and 16q Treated With Regimen M Stage IV With Non-lung Disease Treated With Regimen M Stage IV With Lung Metastases
Hide Arm/Group Description Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A. Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A. Stage III/IV with LOH 1p and 16q treated with Regimen M. Stage IV with non-lung disease treated with Regimen M. Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
Period Title: Overall Study
Started 120 135 52 50 23
Completed 107 132 50 37 9
Not Completed 13 3 2 13 14
Reason Not Completed
Death             0             0             0             2             0
Lack of Efficacy             6             1             0             4             3
Physician Decision             6             2             1             2             3
Withdrawal by Subject             0             0             0             1             0
Refusal of further protocol therapy             1             0             1             1             7
On more than 1 tumor therapeutic study             0             0             0             2             0
Delayed nephrectomy and anaplasia             0             0             0             1             1
Arm/Group Title Stage IV and Rapid Complete Response (RCR) of Lung Metastases Stage IV and Slow Incomplete Response (SIR) of Lung Metastases Stage III/IV With LOH 1p and 16q Treated With Regimen M Stage IV With Non-lung Disease Treated With Regimen M Stage IV With Lung Metastases Total
Hide Arm/Group Description Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A. Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A. Stage III/IV with LOH 1p and 16q treated with Regimen M. Stage IV with non-lung disease treated with Regimen M. Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6. Total of all reporting groups
Overall Number of Baseline Participants 120 135 52 50 23 380
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 120 participants 135 participants 52 participants 50 participants 23 participants 380 participants
54.94  (36.27) 55.07  (27.16) 52.16  (28.64) 69.58  (39.24) 56.06  (23.71) 56.60  (32.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 135 participants 52 participants 50 participants 23 participants 380 participants
Female
65
  54.2%
71
  52.6%
30
  57.7%
31
  62.0%
8
  34.8%
205
  53.9%
Male
55
  45.8%
64
  47.4%
22
  42.3%
19
  38.0%
15
  65.2%
175
  46.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 135 participants 52 participants 50 participants 23 participants 380 participants
Hispanic or Latino
12
  10.0%
18
  13.3%
6
  11.5%
12
  24.0%
3
  13.0%
51
  13.4%
Not Hispanic or Latino
104
  86.7%
108
  80.0%
42
  80.8%
36
  72.0%
18
  78.3%
308
  81.1%
Unknown or Not Reported
4
   3.3%
9
   6.7%
4
   7.7%
2
   4.0%
2
   8.7%
21
   5.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 135 participants 52 participants 50 participants 23 participants 380 participants
American Indian or Alaska Native
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Asian
2
   1.7%
2
   1.5%
0
   0.0%
2
   4.0%
1
   4.3%
7
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
21
  17.5%
22
  16.3%
10
  19.2%
4
   8.0%
1
   4.3%
58
  15.3%
White
80
  66.7%
94
  69.6%
38
  73.1%
39
  78.0%
18
  78.3%
269
  70.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
16
  13.3%
17
  12.6%
4
   7.7%
5
  10.0%
3
  13.0%
45
  11.8%
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stage IV and Rapid Complete Response (RCR) of Lung Metastases
Hide Arm/Group Description:
Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
Overall Number of Participants Analyzed 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.79
(0.70 to 0.87)
2.Primary Outcome
Title Event Free Survival (EFS) Probability
Hide Description Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Time Frame At 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes only eligible patients.
Arm/Group Title Stage IV and Slow Incomplete Response (SIR) of Lung Metastases
Hide Arm/Group Description:

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

doxorubicin hydrochloride: Given IV

liposomal vincristine sulfate: Given IV

conventional surgery

3-dimensional conformal radiation therapy

dactinomycin: Given IV

cyclophosphamide: Given IV

etoposide: Given IV

Overall Number of Participants Analyzed 135
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of EFS at 4 years
0.89
(0.82 to 0.95)
3.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 At 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients were included in this analysis.
Arm/Group Title Stage III/IV With LOH 1p and 16q Treated With Regimen M Stage IV With Non-lung Disease Treated With Regimen M
Hide Arm/Group Description:

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

doxorubicin hydrochloride: Given IV

liposomal vincristine sulfate: Given IV

conventional surgery

3-dimensional conformal radiation therapy

dactinomycin: Given IV

cyclophosphamide: Given IV

etoposide: Given IV

Stage IV with non-lung disease treated with Regimen M

doxorubicin hydrochloride: Given IV

liposomal vincristine sulfate: Given IV

conventional surgery

dactinomycin: Given IV

cyclophosphamide: Given IV

etoposide: Given IV

Overall Number of Participants Analyzed 52 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of EFS at 4 years
0.90
(0.80 to 1)
0.73
(0.59 to 0.88)
4.Secondary Outcome
Title Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease
Hide Description Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Time Frame At 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is eligible stage (stg) IV patients (pts) with lung mets only. On Participant Flow table, these pts include 120 RCR, 135 SIR, 21 stg IV with LOH (of 52 when including stg III), and 23 stg IV with lung mets (off therapy before week 6). A total of 299 stg IV pts, exceeding the total number of participant (297) analyzed for OM 4.
Arm/Group Title Lung Mets <= 1cm Lung Mets > 1cm
Hide Arm/Group Description:
Lung mets <= 1cm
Lung mets > 1cm
Overall Number of Participants Analyzed 147 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.88
(0.82 to 0.95)
0.82
(0.75 to 0.90)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stage IV and Rapid Complete Response (RCR) of Lung Metastases Stage IV and Slow Incomplete Response (SIR) of Lung Metastases Stage III/IV With LOH 1p and 16q Treated With Regimen M Stage IV With Non-lung Disease Treated With Regimen M Stage IV With Lung Metastases
Hide Arm/Group Description Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A. Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A. Stage III/IV with LOH 1p and 16q treated with Regimen M. Stage IV with non-lung disease treated with Regimen M. Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
All-Cause Mortality
Stage IV and Rapid Complete Response (RCR) of Lung Metastases Stage IV and Slow Incomplete Response (SIR) of Lung Metastases Stage III/IV With LOH 1p and 16q Treated With Regimen M Stage IV With Non-lung Disease Treated With Regimen M Stage IV With Lung Metastases
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Stage IV and Rapid Complete Response (RCR) of Lung Metastases Stage IV and Slow Incomplete Response (SIR) of Lung Metastases Stage III/IV With LOH 1p and 16q Treated With Regimen M Stage IV With Non-lung Disease Treated With Regimen M Stage IV With Lung Metastases
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/120 (2.50%)      10/135 (7.41%)      3/52 (5.77%)      11/50 (22.00%)      0/23 (0.00%)    
Blood and lymphatic system disorders           
Bone marrow hypocellular  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Cardiac disorders           
Cardiac arrest  1/120 (0.83%)  1 0/135 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Pericardial effusion  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Gastrointestinal disorders           
Ileus  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Intra-abdominal hemorrhage  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Small intestinal obstruction  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
General disorders           
Death NOS  2/120 (1.67%)  2 3/135 (2.22%)  3 2/52 (3.85%)  2 3/50 (6.00%)  3 0/23 (0.00%)  0
Hepatobiliary disorders           
Hepatobiliary disorders - Other specify  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Infections and infestations           
Infections and infestations - Other specify  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Sepsis  0/120 (0.00%)  0 2/135 (1.48%)  2 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Injury, poisoning and procedural complications           
Postoperative hemorrhage  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Investigations           
Cardiac troponin I increased  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
CPK increased  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Neutrophil count decreased  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Platelet count decreased  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
White blood cell decreased  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Metabolism and nutrition disorders           
Tumor lysis syndrome  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Neoplasms benign malignant and unspecified (incl cy  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Treatment related secondary malignancy  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Renal and urinary disorders           
Proteinuria  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Urinary tract obstruction  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pneumonitis  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Pulmonary hypertension  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Respiratory failure  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Respiratory thoracic and mediastinal disorders - Ot  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  2 0/23 (0.00%)  0
1
Term from vocabulary, CTCv4
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stage IV and Rapid Complete Response (RCR) of Lung Metastases Stage IV and Slow Incomplete Response (SIR) of Lung Metastases Stage III/IV With LOH 1p and 16q Treated With Regimen M Stage IV With Non-lung Disease Treated With Regimen M Stage IV With Lung Metastases
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/120 (9.17%)      90/135 (66.67%)      35/52 (67.31%)      37/50 (74.00%)      1/23 (4.35%)    
Blood and lymphatic system disorders           
Anemia  0/120 (0.00%)  0 3/135 (2.22%)  4 2/52 (3.85%)  2 2/50 (4.00%)  2 0/23 (0.00%)  0
Blood and lymphatic system disorders - Other specif  1/120 (0.83%)  1 0/135 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Febrile neutropenia  0/120 (0.00%)  0 53/135 (39.26%)  77 21/52 (40.38%)  27 20/50 (40.00%)  23 1/23 (4.35%)  2
Cardiac disorders           
Cardiac arrest  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Left ventricular systolic dysfunction  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Sinus tachycardia  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Ear and labyrinth disorders           
Ear pain  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Middle ear inflammation  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  0/120 (0.00%)  0 1/135 (0.74%)  1 1/52 (1.92%)  1 2/50 (4.00%)  2 0/23 (0.00%)  0
Colitis  0/120 (0.00%)  0 2/135 (1.48%)  2 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Diarrhea  0/120 (0.00%)  0 2/135 (1.48%)  2 1/52 (1.92%)  1 2/50 (4.00%)  2 0/23 (0.00%)  0
Enterocolitis  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 1/50 (2.00%)  1 0/23 (0.00%)  0
Gastroparesis  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Ileal obstruction  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Ileus  2/120 (1.67%)  2 2/135 (1.48%)  2 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Jejunal obstruction  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Mucositis oral  1/120 (0.83%)  1 4/135 (2.96%)  4 2/52 (3.85%)  2 3/50 (6.00%)  3 0/23 (0.00%)  0
Nausea  0/120 (0.00%)  0 5/135 (3.70%)  5 2/52 (3.85%)  3 4/50 (8.00%)  4 0/23 (0.00%)  0
Oral pain  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Small intestinal obstruction  0/120 (0.00%)  0 3/135 (2.22%)  3 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Typhlitis  0/120 (0.00%)  0 2/135 (1.48%)  2 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Vomiting  0/120 (0.00%)  0 3/135 (2.22%)  3 3/52 (5.77%)  3 6/50 (12.00%)  7 1/23 (4.35%)  1
General disorders           
Fatigue  0/120 (0.00%)  0 1/135 (0.74%)  1 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Fever  0/120 (0.00%)  0 5/135 (3.70%)  6 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Infusion related reaction  0/120 (0.00%)  0 1/135 (0.74%)  2 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Pain  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 1/50 (2.00%)  1 0/23 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis  1/120 (0.83%)  1 0/135 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Hepatobiliary disorders - Other specify  0/120 (0.00%)  0 1/135 (0.74%)  1 1/52 (1.92%)  1 1/50 (2.00%)  1 0/23 (0.00%)  0
Immune system disorders           
Anaphylaxis  0/120 (0.00%)  0 1/135 (0.74%)  1 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Infections and infestations           
Abdominal infection  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 1/50 (2.00%)  1 0/23 (0.00%)  0
Bladder infection  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Catheter related infection  0/120 (0.00%)  0 4/135 (2.96%)  4 1/52 (1.92%)  1 2/50 (4.00%)  2 0/23 (0.00%)  0
Device related infection  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Duodenal infection  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Enterocolitis infectious  0/120 (0.00%)  0 4/135 (2.96%)  4 1/52 (1.92%)  1 1/50 (2.00%)  1 0/23 (0.00%)  0
Infections and infestations - Other specify  2/120 (1.67%)  2 20/135 (14.81%)  22 11/52 (21.15%)  17 9/50 (18.00%)  11 0/23 (0.00%)  0
Lung infection  0/120 (0.00%)  0 4/135 (2.96%)  4 2/52 (3.85%)  2 1/50 (2.00%)  1 0/23 (0.00%)  0
Mucosal infection  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Otitis media  0/120 (0.00%)  0 2/135 (1.48%)  2 2/52 (3.85%)  2 0/50 (0.00%)  0 0/23 (0.00%)  0
Pharyngitis  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Sepsis  0/120 (0.00%)  0 3/135 (2.22%)  3 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Skin infection  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Stoma site infection  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Upper respiratory infection  0/120 (0.00%)  0 3/135 (2.22%)  4 2/52 (3.85%)  3 0/50 (0.00%)  0 0/23 (0.00%)  0
Urinary tract infection  1/120 (0.83%)  1 3/135 (2.22%)  3 2/52 (3.85%)  3 4/50 (8.00%)  5 0/23 (0.00%)  0
Vulval infection  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Wound infection  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Injury, poisoning and procedural complications           
Vascular access complication  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Investigations           
Activated partial thromboplastin time prolonged  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Alanine aminotransferase increased  0/120 (0.00%)  0 5/135 (3.70%)  6 3/52 (5.77%)  3 6/50 (12.00%)  6 1/23 (4.35%)  1
Aspartate aminotransferase increased  0/120 (0.00%)  0 2/135 (1.48%)  2 2/52 (3.85%)  2 3/50 (6.00%)  3 1/23 (4.35%)  1
Blood bilirubin increased  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 3/50 (6.00%)  3 0/23 (0.00%)  0
Creatinine increased  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
GGT increased  0/120 (0.00%)  0 2/135 (1.48%)  2 1/52 (1.92%)  1 2/50 (4.00%)  3 0/23 (0.00%)  0
Lipase increased  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Lymphocyte count decreased  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Neutrophil count decreased  1/120 (0.83%)  1 4/135 (2.96%)  6 3/52 (5.77%)  5 2/50 (4.00%)  2 0/23 (0.00%)  0
Platelet count decreased  0/120 (0.00%)  0 3/135 (2.22%)  4 3/52 (5.77%)  4 2/50 (4.00%)  2 0/23 (0.00%)  0
Weight loss  0/120 (0.00%)  0 1/135 (0.74%)  1 2/52 (3.85%)  2 3/50 (6.00%)  4 0/23 (0.00%)  0
White blood cell decreased  0/120 (0.00%)  0 2/135 (1.48%)  3 2/52 (3.85%)  2 1/50 (2.00%)  1 0/23 (0.00%)  0
Metabolism and nutrition disorders           
Acidosis  0/120 (0.00%)  0 2/135 (1.48%)  2 2/52 (3.85%)  2 1/50 (2.00%)  1 0/23 (0.00%)  0
Anorexia  0/120 (0.00%)  0 10/135 (7.41%)  12 5/52 (9.62%)  7 9/50 (18.00%)  14 0/23 (0.00%)  0
Dehydration  0/120 (0.00%)  0 10/135 (7.41%)  10 3/52 (5.77%)  3 1/50 (2.00%)  1 0/23 (0.00%)  0
Hypercalcemia  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Hyperglycemia  1/120 (0.83%)  1 3/135 (2.22%)  3 3/52 (5.77%)  4 1/50 (2.00%)  1 0/23 (0.00%)  0
Hyperkalemia  0/120 (0.00%)  0 1/135 (0.74%)  1 1/52 (1.92%)  1 1/50 (2.00%)  1 0/23 (0.00%)  0
Hypoalbuminemia  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 2/50 (4.00%)  2 0/23 (0.00%)  0
Hypocalcemia  2/120 (1.67%)  2 1/135 (0.74%)  1 3/52 (5.77%)  3 3/50 (6.00%)  3 0/23 (0.00%)  0
Hypokalemia  0/120 (0.00%)  0 6/135 (4.44%)  6 6/52 (11.54%)  6 3/50 (6.00%)  3 0/23 (0.00%)  0
Hyponatremia  0/120 (0.00%)  0 3/135 (2.22%)  3 1/52 (1.92%)  1 3/50 (6.00%)  4 0/23 (0.00%)  0
Hypophosphatemia  0/120 (0.00%)  0 1/135 (0.74%)  1 2/52 (3.85%)  2 0/50 (0.00%)  0 0/23 (0.00%)  0
Obesity  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Bone pain  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Buttock pain  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Chest wall pain  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Generalized muscle weakness  0/120 (0.00%)  0 1/135 (0.74%)  1 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Muscle weakness lower limb  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Muscle weakness upper limb  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Pain in extremity  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Soft tissue necrosis lower limb  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Nervous system disorders           
Headache  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Peripheral motor neuropathy  0/120 (0.00%)  0 4/135 (2.96%)  5 3/52 (5.77%)  4 2/50 (4.00%)  5 1/23 (4.35%)  1
Peripheral sensory neuropathy  0/120 (0.00%)  0 1/135 (0.74%)  1 1/52 (1.92%)  1 1/50 (2.00%)  2 0/23 (0.00%)  0
Seizure  0/120 (0.00%)  0 2/135 (1.48%)  2 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Syncope  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Psychiatric disorders           
Depression  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Suicidal ideation  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  0/120 (0.00%)  0 2/135 (1.48%)  2 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Cystitis noninfective  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Hematuria  0/120 (0.00%)  0 1/135 (0.74%)  1 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Proteinuria  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 0/23 (0.00%)  0
Urinary tract obstruction  0/120 (0.00%)  0 2/135 (1.48%)  2 0/52 (0.00%)  0 1/50 (2.00%)  2 0/23 (0.00%)  0
Urinary tract pain  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Adult respiratory distress syndrome  0/120 (0.00%)  0 2/135 (1.48%)  3 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Dyspnea  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Epistaxis  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Hypoxia  0/120 (0.00%)  0 2/135 (1.48%)  2 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Pneumonitis  0/120 (0.00%)  0 0/135 (0.00%)  0 1/52 (1.92%)  1 2/50 (4.00%)  2 0/23 (0.00%)  0
Pneumothorax  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Pulmonary hypertension  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 2/50 (4.00%)  2 0/23 (0.00%)  0
Respiratory failure  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders           
Pruritus  0/120 (0.00%)  0 1/135 (0.74%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/23 (0.00%)  0
Rash maculo-papular  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Vascular disorders           
Hematoma  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (0.00%)  0
Hypertension  0/120 (0.00%)  0 3/135 (2.22%)  5 0/52 (0.00%)  0 3/50 (6.00%)  4 0/23 (0.00%)  0
Hypotension  0/120 (0.00%)  0 2/135 (1.48%)  2 2/52 (3.85%)  2 1/50 (2.00%)  1 0/23 (0.00%)  0
Thromboembolic event  0/120 (0.00%)  0 0/135 (0.00%)  0 0/52 (0.00%)  0 2/50 (4.00%)  3 0/23 (0.00%)  0
Vascular disorders - Other specify  0/120 (0.00%)  0 2/135 (1.48%)  2 0/52 (0.00%)  0 1/50 (2.00%)  1 0/23 (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.
Must obtain prior Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Childrens's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00379340    
Other Study ID Numbers: AREN0533
NCI-2009-00419 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000496508 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
COG-AREN0533 ( Other Identifier: Children's Oncology Group )
First Submitted: September 19, 2006
First Posted: September 21, 2006
Results First Submitted: December 6, 2016
Results First Posted: June 14, 2017
Last Update Posted: September 17, 2019