Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
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| ClinicalTrials.gov Identifier: NCT00379340 |
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Recruitment Status : Unknown
Verified December 2016 by Children's Oncology Group.
Recruitment status was: Active, not recruiting
First Posted : September 21, 2006
Results First Posted : June 14, 2017
Last Update Posted : March 24, 2020
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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| 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 |
Participant Flow
| 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 |
|---|---|---|---|---|---|
 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 |
Baseline Characteristics
| 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 | |
|---|---|---|---|---|---|---|---|
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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 | |
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Baseline Analysis Population Description |
[Not Specified]
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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) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 120 participants | 135 participants | 52 participants | 50 participants | 23 participants | 380 participants | |
| Female |
65 54.2%
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71 52.6%
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30 57.7%
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31 62.0%
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8 34.8%
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205 53.9%
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| Male |
55 45.8%
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64 47.4%
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22 42.3%
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19 38.0%
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15 65.2%
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175 46.1%
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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%
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18 13.3%
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6 11.5%
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12 24.0%
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3 13.0%
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51 13.4%
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| Not Hispanic or Latino |
104 86.7%
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108 80.0%
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42 80.8%
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36 72.0%
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18 78.3%
|
308 81.1%
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|
| Unknown or Not Reported |
4 3.3%
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9 6.7%
|
4 7.7%
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2 4.0%
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2 8.7%
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21 5.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 120 participants | 135 participants | 52 participants | 50 participants | 23 participants | 380 participants | |
| American Indian or Alaska Native |
1 0.8%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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1 0.3%
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| Asian |
2 1.7%
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2 1.5%
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0 0.0%
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2 4.0%
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1 4.3%
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7 1.8%
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|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
21 17.5%
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22 16.3%
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10 19.2%
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4 8.0%
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1 4.3%
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58 15.3%
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| White |
80 66.7%
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94 69.6%
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38 73.1%
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39 78.0%
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18 78.3%
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269 70.8%
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| More than one race |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Unknown or Not Reported |
16 13.3%
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17 12.6%
|
4 7.7%
|
5 10.0%
|
3 13.0%
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45 11.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
| Name/Title: | Results Reporting Coordinator |
| Organization: | Childrens's Oncology Group |
| Phone: | 626-447-0064 |
| EMail: | resultsreportingcoordinator@childrensoncologygroup.org |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | March 24, 2020 |