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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01190930




Registration number
NCT01190930
Ethics application status
Date submitted
27/08/2010
Date registered
30/08/2010

Titles & IDs
Public title
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
Scientific title
Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
Secondary ID [1] 0 0
NCI-2011-02599
Secondary ID [2] 0 0
AALL0932
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia 0 0
Adult B Lymphoblastic Lymphoma 0 0
Ann Arbor Stage I B Lymphoblastic Lymphoma 0 0
Ann Arbor Stage II B Lymphoblastic Lymphoma 0 0
Childhood B Acute Lymphoblastic Leukemia 0 0
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 0 0
Childhood B Lymphoblastic Lymphoma 0 0
Down Syndrome 0 0
Hypodiploid B Acute Lymphoblastic Leukemia 0 0
Philadelphia Chromosome Positive 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Human Genetics and Inherited Disorders 0 0 0 0
Down's syndrome
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Doxorubicin Hydrochloride
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Pegaspargase
Other interventions - Quality-of-Life Assessment
Other interventions - Questionnaire Administration
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine Sulfate

Experimental: Arm A (risk-adapted chemotherapy) - Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Experimental: Arm B (risk-adapted chemotherapy) - Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Experimental: Arm B-LLy (4-week cycle maintenance) - See Detailed Description.

Experimental: Arm C (risk-adapted chemotherapy) - Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Experimental: Arm D (risk-adapted chemotherapy) - Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Experimental: Arm LR-C (risk-adapted chemotherapy) - Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.

Experimental: Arm LR-M (risk-adapted chemotherapy) - Patients receive consolidation and maintenance therapy. See detailed description.

Experimental: Arm SR DS (12-week cycle maintenance) - See Detailed Description


Treatment: Drugs: Cyclophosphamide
Given IV

Treatment: Drugs: Cytarabine
Given IT, IV, or SC

Treatment: Drugs: Dexamethasone
Given orally (PO) or IV

Treatment: Drugs: Doxorubicin Hydrochloride
Given IV

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Treatment: Drugs: Leucovorin Calcium
Given PO

Treatment: Drugs: Mercaptopurine
Given PO

Treatment: Drugs: Methotrexate
Given IT, PO, or IV

Treatment: Drugs: Pegaspargase
Given IV

Other interventions: Quality-of-Life Assessment
Ancillary studies

Other interventions: Questionnaire Administration
Ancillary studies

Treatment: Drugs: Thioguanine
Given PO

Treatment: Drugs: Vincristine Sulfate
Given IV
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
Timepoint [1] 0 0
5.7 years
Primary outcome [2] 0 0
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
Timepoint [2] 0 0
5.7 years
Primary outcome [3] 0 0
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
Timepoint [3] 0 0
5.1 years
Primary outcome [4] 0 0
DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
Timepoint [4] 0 0
5.1 years
Primary outcome [5] 0 0
Sample Collection of Central Path Review Slides in B-LLy Patients
Timepoint [5] 0 0
Up to 1 month
Primary outcome [6] 0 0
Event Free Survival (EFS) for B-LLy Patients
Timepoint [6] 0 0
5 years
Primary outcome [7] 0 0
Overall Survival (OS) for B-LLy Patients
Timepoint [7] 0 0
5 years
Secondary outcome [1] 0 0
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
Timepoint [1] 0 0
2 Months
Secondary outcome [2] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
Timepoint [3] 0 0
1.7 years
Secondary outcome [4] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Timepoint [4] 0 0
2.5 years
Secondary outcome [5] 0 0
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
Timepoint [5] 0 0
3.2 years
Secondary outcome [6] 0 0
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
Timepoint [6] 0 0
2 Months
Secondary outcome [7] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
Timepoint [7] 0 0
1 Year
Secondary outcome [8] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
Timepoint [8] 0 0
1.7 years
Secondary outcome [9] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Timepoint [9] 0 0
2.4 Years
Secondary outcome [10] 0 0
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
Timepoint [10] 0 0
3.2 years
Secondary outcome [11] 0 0
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School
Timepoint [11] 0 0
2 Months
Secondary outcome [12] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School
Timepoint [12] 0 0
1 Year
Secondary outcome [13] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School
Timepoint [13] 0 0
1.7 Years
Secondary outcome [14] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Timepoint [14] 0 0
2.4 years
Secondary outcome [15] 0 0
Burden of Therapy in Boy AR Patients Overall at End of Therapy: School
Timepoint [15] 0 0
3.2 Years
Secondary outcome [16] 0 0
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
Timepoint [16] 0 0
2 Months
Secondary outcome [17] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
Timepoint [17] 0 0
1 Year
Secondary outcome [18] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
Timepoint [18] 0 0
1.7 Years
Secondary outcome [19] 0 0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Timepoint [19] 0 0
2.4 Years
Secondary outcome [20] 0 0
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
Timepoint [20] 0 0
3.2 Years
Secondary outcome [21] 0 0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
Timepoint [21] 0 0
1.7 years
Secondary outcome [22] 0 0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Timepoint [22] 0 0
2.4 Years
Secondary outcome [23] 0 0
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
Timepoint [23] 0 0
3.2 Years
Secondary outcome [24] 0 0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
Timepoint [24] 0 0
1.7 Years
Secondary outcome [25] 0 0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Timepoint [25] 0 0
2.4 Years
Secondary outcome [26] 0 0
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
Timepoint [26] 0 0
3.2 Years
Secondary outcome [27] 0 0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School
Timepoint [27] 0 0
1.7 Years
Secondary outcome [28] 0 0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Timepoint [28] 0 0
2.4 Years
Secondary outcome [29] 0 0
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School
Timepoint [29] 0 0
3.2 Years
Secondary outcome [30] 0 0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
Timepoint [30] 0 0
1.7 Years
Secondary outcome [31] 0 0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Timepoint [31] 0 0
2.4 Years
Secondary outcome [32] 0 0
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
Timepoint [32] 0 0
3.2 Years
Secondary outcome [33] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right
Timepoint [33] 0 0
2 Months
Secondary outcome [34] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left
Timepoint [34] 0 0
2 Months
Secondary outcome [35] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right
Timepoint [35] 0 0
1 Year
Secondary outcome [36] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left
Timepoint [36] 0 0
1 Year
Secondary outcome [37] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Timepoint [37] 0 0
2.4 Years
Secondary outcome [38] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Timepoint [38] 0 0
2.4 Years
Secondary outcome [39] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right
Timepoint [39] 0 0
4.2 Years
Secondary outcome [40] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left
Timepoint [40] 0 0
4.2 Years
Secondary outcome [41] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Timepoint [41] 0 0
2.4 Years
Secondary outcome [42] 0 0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Timepoint [42] 0 0
2.4 Years

Eligibility
Key inclusion criteria
* B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932

* Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932
* B-ALL patients must have an initial white blood cell count < 50,000/uL
* Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible

* Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met
Minimum age
1 Year
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932

* Patients receiving prior steroid therapy may be eligible for AALL0932
* Patients with central nervous system 3 (CNS3) leukemia

* CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy
* B-ALL patients with testicular leukemia are not eligible for AALL0932
* For B-LLy patients the following additional exclusion criteria apply:

* T-lymphoblastic lymphoma
* Morphologically unclassifiable lymphoma
* Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
* CNS3-positive disease or testicular involvement
* M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow
* Female patients who are pregnant are ineligible
* Lactating females are not eligible unless they have agreed not to breastfeed their infants
* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
* Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
Accrual to date
Final
9350
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - Hunter Regional Mail Centre
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [5] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [6] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [7] 0 0
Monash Medical Center-Clayton Campus - Clayton
Recruitment hospital [8] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [9] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2310 - Hunter Regional Mail Centre
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
Delaware
Country [9] 0 0
United States of America
State/province [9] 0 0
District of Columbia
Country [10] 0 0
United States of America
State/province [10] 0 0
Florida
Country [11] 0 0
United States of America
State/province [11] 0 0
Georgia
Country [12] 0 0
United States of America
State/province [12] 0 0
Hawaii
Country [13] 0 0
United States of America
State/province [13] 0 0
Idaho
Country [14] 0 0
United States of America
State/province [14] 0 0
Illinois
Country [15] 0 0
United States of America
State/province [15] 0 0
Indiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Iowa
Country [17] 0 0
United States of America
State/province [17] 0 0
Kentucky
Country [18] 0 0
United States of America
State/province [18] 0 0
Louisiana
Country [19] 0 0
United States of America
State/province [19] 0 0
Maine
Country [20] 0 0
United States of America
State/province [20] 0 0
Maryland
Country [21] 0 0
United States of America
State/province [21] 0 0
Massachusetts
Country [22] 0 0
United States of America
State/province [22] 0 0
Michigan
Country [23] 0 0
United States of America
State/province [23] 0 0
Minnesota
Country [24] 0 0
United States of America
State/province [24] 0 0
Mississippi
Country [25] 0 0
United States of America
State/province [25] 0 0
Missouri
Country [26] 0 0
United States of America
State/province [26] 0 0
Nebraska
Country [27] 0 0
United States of America
State/province [27] 0 0
Nevada
Country [28] 0 0
United States of America
State/province [28] 0 0
New Hampshire
Country [29] 0 0
United States of America
State/province [29] 0 0
New Jersey
Country [30] 0 0
United States of America
State/province [30] 0 0
New Mexico
Country [31] 0 0
United States of America
State/province [31] 0 0
New York
Country [32] 0 0
United States of America
State/province [32] 0 0
North Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
North Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Ohio
Country [35] 0 0
United States of America
State/province [35] 0 0
Oklahoma
Country [36] 0 0
United States of America
State/province [36] 0 0
Oregon
Country [37] 0 0
United States of America
State/province [37] 0 0
Pennsylvania
Country [38] 0 0
United States of America
State/province [38] 0 0
South Carolina
Country [39] 0 0
United States of America
State/province [39] 0 0
South Dakota
Country [40] 0 0
United States of America
State/province [40] 0 0
Tennessee
Country [41] 0 0
United States of America
State/province [41] 0 0
Texas
Country [42] 0 0
United States of America
State/province [42] 0 0
Utah
Country [43] 0 0
United States of America
State/province [43] 0 0
Vermont
Country [44] 0 0
United States of America
State/province [44] 0 0
Virginia
Country [45] 0 0
United States of America
State/province [45] 0 0
Washington
Country [46] 0 0
United States of America
State/province [46] 0 0
West Virginia
Country [47] 0 0
United States of America
State/province [47] 0 0
Wisconsin
Country [48] 0 0
Canada
State/province [48] 0 0
Alberta
Country [49] 0 0
Canada
State/province [49] 0 0
British Columbia
Country [50] 0 0
Canada
State/province [50] 0 0
Manitoba
Country [51] 0 0
Canada
State/province [51] 0 0
Newfoundland and Labrador
Country [52] 0 0
Canada
State/province [52] 0 0
Nova Scotia
Country [53] 0 0
Canada
State/province [53] 0 0
Ontario
Country [54] 0 0
Canada
State/province [54] 0 0
Quebec
Country [55] 0 0
Canada
State/province [55] 0 0
Saskatchewan
Country [56] 0 0
Ireland
State/province [56] 0 0
Co Dublin
Country [57] 0 0
New Zealand
State/province [57] 0 0
Auckland
Country [58] 0 0
New Zealand
State/province [58] 0 0
Christchurch
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Puerto Rico
State/province [59] 0 0
San Juan
Country [60] 0 0
Switzerland
State/province [60] 0 0
Geneva
Country [61] 0 0
Switzerland
State/province [61] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne L Angiolillo
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf
Statistical analysis plan Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf
Study protocol Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf
Statistical analysis plan Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf
Study protocol Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf
Statistical analysis plan Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf
Study protocol Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf
Statistical analysis plan Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf
Study protocol Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf
Statistical analysis plan Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/30/NCT01190930/Prot_SAP_000.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01190930