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Combination Chemotherapy and Surgery in Treating Young Patients With 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: NCT00945009
Recruitment Status : Active, not recruiting
First Posted : July 23, 2009
Results First Posted : March 5, 2019
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 Adult Kidney Wilms Tumor
Beckwith-Wiedemann Syndrome
Childhood Kidney Wilms Tumor
Diffuse Hyperplastic Perilobar Nephroblastomatosis
Hemihypertrophy
Rhabdoid Tumor of the Kidney
Stage I Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Stage V Kidney Wilms Tumor
Interventions Biological: Dactinomycin
Drug: Doxorubicin Hydrochloride
Radiation: Radiation Therapy
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Enrollment 249
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 (Bilateral Wilms Tumors) Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) Arm 3 (DHPLN)
Hide Arm/Group Description

Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Period Title: Overall Study
Started 201 39 9
Completed 156 32 6
Not Completed 45 7 3
Reason Not Completed
Lack of Efficacy             10             0             0
Physician Decision             21             4             3
Protocol Violation             6             1             0
Withdrawal by Subject             1             0             0
Ineligible             6             1             0
Inevaluable             0             1             0
Refusal of further protocol             1             0             0
Arm/Group Title Arm 1 (Bilateral Wilms Tumors) Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) Arm 3 (DHPLN) Total
Hide Arm/Group Description

Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 201 39 9 249
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Months
Number Analyzed 201 participants 39 participants 9 participants 249 participants
32.03  (22.22) 34.70  (22.12) 13.26  (8.70) 31.78  (22.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 39 participants 9 participants 249 participants
Female
119
  59.2%
23
  59.0%
5
  55.6%
147
  59.0%
Male
82
  40.8%
16
  41.0%
4
  44.4%
102
  41.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 39 participants 9 participants 249 participants
Hispanic or Latino
27
  13.4%
3
   7.7%
0
   0.0%
30
  12.0%
Not Hispanic or Latino
168
  83.6%
35
  89.7%
8
  88.9%
211
  84.7%
Unknown or Not Reported
6
   3.0%
1
   2.6%
1
  11.1%
8
   3.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 39 participants 9 participants 249 participants
American Indian or Alaska Native
0
   0.0%
1
   2.6%
0
   0.0%
1
   0.4%
Asian
3
   1.5%
1
   2.6%
0
   0.0%
4
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
31
  15.4%
5
  12.8%
1
  11.1%
37
  14.9%
White
142
  70.6%
29
  74.4%
7
  77.8%
178
  71.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
25
  12.4%
3
   7.7%
1
  11.1%
29
  11.6%
1.Primary Outcome
Title Event-Free Survival (EFS)
Hide Description Probability of no relapse, secondary malignancy, or death whichever occurs first
Time Frame 4 years from study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible BWT patients. 6 patients were excluded due to ineligibility and 6 patients were excluded due to protocol violation.
Arm/Group Title Arm 1 (Bilateral Wilms Tumors)
Hide Arm/Group Description:

Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Overall Number of Participants Analyzed 189
Mean (95% Confidence Interval)
Unit of Measure: Probability
0.82
(0.74 to 0.91)
2.Primary Outcome
Title Kidney Preservation After Preoperative Chemotherapy
Hide Description Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT).
Time Frame 12 weeks from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable Bilateral Wilms Tumor patients who completed pre-nephrectomy chemotherapy (VAD). 49 patients who did not complete VAD were excluded.
Arm/Group Title Arm 1 (Bilateral Wilms Tumors)
Hide Arm/Group Description:

Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Overall Number of Participants Analyzed 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
39
(31 to 47)
3.Primary Outcome
Title Number of Patients Without Complete Removal of at Least One Kidney
Hide Description To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development.
Time Frame 12 weeks from the study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients with diffuse hyperplastic perilobar nephroblastomatosis (DPHLN).
Arm/Group Title Arm 3 (DHPLN)
Hide Arm/Group Description:
Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
7
  77.8%
4.Primary Outcome
Title Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy
Hide Description Percentage of patients who experienced partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin.
Time Frame 12 weeks from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients with unilateral high risk tumors who had partial or complete nephrectomy. 16 total patients were excluded (1 ineligible, 1 inevaluable, 1 violated protocol, and 13 did not have definitive surgery (partial or complete nephrectomy).
Arm/Group Title Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)
Hide Arm/Group Description:

Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
57
(37 to 77)
5.Primary Outcome
Title Percentage of Patients Who Had Definitive Surgical Treatment
Hide Description Percentage of Bilateral Wilms Tumor (BWT) patients who undergo definitive surgery by week 12 after initiation of chemotherapy.
Time Frame 12 weeks from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable Bilateral Wilms Tumor patients. 6 patients were excluded due to ineligible and 6 patients were excluded due to protocol violation.
Arm/Group Title Arm 1 (Bilateral Wilms Tumors)
Hide Arm/Group Description:

Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Overall Number of Participants Analyzed 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85
(80 to 90)
Time Frame From enrollment to up to 10 years of follow-up
Adverse Event Reporting Description Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
 
Arm/Group Title Arm 1 (Bilateral Wilms Tumors) Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) Arm 3 (DHPLN)
Hide Arm/Group Description

Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.

Dactinomycin: Given IV

Doxorubicin Hydrochloride: Given IV

Radiation Therapy: Undergo radiation therapy

Therapeutic Conventional Surgery: Undergo surgical resection

Vincristine Sulfate: Given IV

All-Cause Mortality
Arm 1 (Bilateral Wilms Tumors) Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) Arm 3 (DHPLN)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/189 (5.29%)      0/36 (0.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
Arm 1 (Bilateral Wilms Tumors) Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) Arm 3 (DHPLN)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/189 (6.35%)      1/36 (2.78%)      0/9 (0.00%)    
General disorders       
24600-Death NOS  1  8/189 (4.23%)  8 0/36 (0.00%)  0 0/9 (0.00%)  0
Hepatobiliary disorders       
40600-Hepatobiliary disorders - Other specify  1  3/189 (1.59%)  3 1/36 (2.78%)  1 0/9 (0.00%)  0
Investigations       
11600-Alanine aminotransferase increased  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
15000-Aspartate aminotransferase increased  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
83600-Urine output decreased  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
Metabolism and nutrition disorders       
43100-Hypokalemia  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
71500-Respiratory failure  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
1
Term from vocabulary, CTCv4
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 (Bilateral Wilms Tumors) Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed) Arm 3 (DHPLN)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/189 (17.99%)      1/36 (2.78%)      0/9 (0.00%)    
Blood and lymphatic system disorders       
13200-Anemia  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
33300-Febrile neutropenia  1  3/189 (1.59%)  4 0/36 (0.00%)  0 0/9 (0.00%)  0
Cardiac disorders       
20100-Cardiac disorders - Other specify  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
78900-Supraventricular tachycardia  1  1/189 (0.53%)  2 0/36 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders       
10300-Abdominal pain  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
23400-Constipation  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
75700-Small intestinal obstruction  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
87900-Vomiting  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
Infections and infestations       
18800-Bronchial infection  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
73700-Sepsis  1  3/189 (1.59%)  3 0/36 (0.00%)  0 0/9 (0.00%)  0
83100-Urinary tract infection  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
Investigations       
11600-Alanine aminotransferase increased  1  1/189 (0.53%)  1 1/36 (2.78%)  2 0/9 (0.00%)  0
15000-Aspartate aminotransferase increased  1  2/189 (1.06%)  2 1/36 (2.78%)  2 0/9 (0.00%)  0
24100-Creatinine increased  1  4/189 (2.12%)  6 0/36 (0.00%)  0 0/9 (0.00%)  0
28600-Ejection fraction decreased  1  1/189 (0.53%)  2 0/36 (0.00%)  0 0/9 (0.00%)  0
58300-Neutrophil count decreased  1  6/189 (3.17%)  8 0/36 (0.00%)  0 0/9 (0.00%)  0
65800-Platelet count decreased  1  2/189 (1.06%)  4 0/36 (0.00%)  0 0/9 (0.00%)  0
83600-Urine output decreased  1  2/189 (1.06%)  2 0/36 (0.00%)  0 0/9 (0.00%)  0
88500-White blood cell decreased  1  2/189 (1.06%)  2 0/36 (0.00%)  0 0/9 (0.00%)  0
Metabolism and nutrition disorders       
10700-Acidosis  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
11900-Alkalosis  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
24700-Dehydration  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
41400-Hyperglycemia  1  2/189 (1.06%)  2 0/36 (0.00%)  0 0/9 (0.00%)  0
41600-Hyperkalemia  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
42500-Hyperuricemia  1  2/189 (1.06%)  2 0/36 (0.00%)  0 0/9 (0.00%)  0
42700-Hypocalcemia  1  4/189 (2.12%)  4 1/36 (2.78%)  1 0/9 (0.00%)  0
42900-Hypoglycemia  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
43100-Hypokalemia  1  5/189 (2.65%)  6 1/36 (2.78%)  1 0/9 (0.00%)  0
43200-Hypomagnesemia  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
43500-Hypophosphatemia  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders       
14000-Aphonia  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
63900-Peripheral motor neuropathy  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
72500-Reversible posterior leukoencephalopathy syndrome  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
Renal and urinary disorders       
11100-Acute kidney injury  1  3/189 (1.59%)  3 0/36 (0.00%)  0 0/9 (0.00%)  0
71000-Renal and urinary disorders - Other specify  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
14100-Apnea  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
15400-Atelectasis  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
27800-Dyspnea  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
43900-Hypoxia  1  2/189 (1.06%)  2 1/36 (2.78%)  1 0/9 (0.00%)  0
50700-Laryngeal edema  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
51300-Laryngeal stenosis  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
66300-Pneumonitis  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
68700-Pulmonary edema  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
71500-Respiratory failure  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
78100-Stridor  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
Vascular disorders       
42100-Hypertension  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
79600-Thromboembolic event  1  1/189 (0.53%)  1 0/36 (0.00%)  0 0/9 (0.00%)  0
1
Term from vocabulary, CTCv4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children'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: NCT00945009    
Other Study ID Numbers: AREN0534
NCI-2011-01953 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000649716
AREN0534 ( Other Identifier: Childrens Oncology Group )
AREN0534 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2009
First Posted: July 23, 2009
Results First Submitted: November 5, 2018
Results First Posted: March 5, 2019
Last Update Posted: September 17, 2019