Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00499616
First received: July 10, 2007
Last updated: June 7, 2013
Last verified: June 2013

July 10, 2007
June 7, 2013
October 2007
June 2014   (final data collection date for primary outcome measure)
Overall survival (OS) rates [ Time Frame: From the date of enrollment until death, or until last contact if the patients is alive, assessed up to 3 years ] [ Designated as safety issue: No ]
A log-rank test comparison of the overall cohort to the analogous cohort on P9641/A3961 will be used. If these are not statistically significantly different, then it is reasonable to assume that a 3-year OS rate consistent with previous studies (> 95%) has been maintained.
  • Overall survival
  • Event-free survival
Complete list of historical versions of study NCT00499616 on ClinicalTrials.gov Archive Site
  • Event-free survival (EFS) rate [ Time Frame: From date of enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death or until last contact if none of these events occur, assessed up to 3 years ] [ Designated as safety issue: No ]
    A log-rank test comparison of the overall cohort to the analogous cohort on P9641/A3961 will be used.
  • Second-event-free survival (E2FS) of intermediate risk patients [ Time Frame: From the time of the first progressive, non-metastatic event until the subsequent occurrence of relapse, progressive disease, secondary malignancy, or death ] [ Designated as safety issue: No ]
    Kaplan-Meier curves and life tables of E2FS and OS (from the time of first event) will be generated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy.
  • Overall survival time [ Time Frame: From the time of the first progressive, non-metastatic event ] [ Designated as safety issue: No ]
    Kaplan-Meier curves and life tables of E2FS and OS (from the time of first event) will be generated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy.
  • Definitive determination of the prognostic ability of 1p and 11q [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q. Definitive determination of the prognostic ability of 1p and 11q will be based on a pooled analysis of all patients in ANBL00B1
  • Comparison between reduce intensity of therapy for patients with stage 4 neuroblastoma and favorable biological features and patients < 1 year of age with stage 4 neuroblastoma treated on COG-A3961 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age.
  • Comparison between reduce intensity of therapy for patients with unfavorable histology neuroblastoma and patients unfavorable histology neuroblastoma treated on COG-A3961 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age
  • Reduced surgical morbidity for patients with stage 4S neuroblastoma [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves and lifetables of EFS and OS rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy. Descriptive analyses will be performed of the symptoms of stage 4S infants.
  • Outcome of patients with stage 4S neuroblastoma who are unable to undergo biopsy for biology-based risk assignment [ Time Frame: From baseline to up to 10 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves and lifetables of EFS and OS rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy. Descriptive analyses will be performed of the symptoms of stage 4S infants.
  • Correlation between extent of surgical resection with the maintenance of local control, EFS and/or OS rates, and surgical complication rate [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    A chi-square test will be performed. To test the predictive ability of the extent of surgical resection for EFS and OS, log rank tests will be performed for various cut-offs: (completer response (CR) vs <CR), (CR, very good partial response (VGPR) vs <VGPR), and (CR/VGPR/PR vs <PR). Descriptive Kaplan-Meier curves will be generated of CR vs VGPR vs PR vs MR vs PD. To test for the association of the extent of surgical resection (CR vs <CR) with surgical complications rate (complications of any kind vs no complications at all), a chi-square test will be performed.
  • Biological surrogate markers [ Time Frame: At baseline and surgery ] [ Designated as safety issue: No ]
    Multivariable analyses will be performed to identify variables of prognostic interest.
  • Proportion of patients with neurologic symptoms overall and type of symptom [ Time Frame: On treatment and post-treatment ] [ Designated as safety issue: No ]
    Descriptive analysis will be used.
  • Association between surgical biopsy technique with adequacy of tissue acquisition for biologic studies, and with complications associated with the biopsy procedure [ Time Frame: During and after surgery ] [ Designated as safety issue: No ]
    A chi-square test will be performed.
  • Prognostic ability of the INRG image-defined risk factor (IDRF) system [ Time Frame: At baseline, during and after completion of study treatment ] [ Designated as safety issue: No ]
    A Kaplan - Meier curves of presence vs absence of one or more IDRFs will be generated, and a log rank test performed to compare them, for EFS and OS. The IDRF data will be used to determine the International Neuroblastoma Risk Group Stage (INRGSS) and Kaplan-Meier curves by INRGSS will be generated. To compare the institutional assessment of IDRFs (presence vs absence) with the central review assessment of IDRFs, a chi-square test will be performed. ROC curves will be generated, and the sensitivity and specificity of the institutional assessment will be calculated
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma

RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy with or without isotretinoin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating young patients with neuroblastoma.

PURPOSE: This phase III trial is comparing different regimens of combination chemotherapy and surgery with or without isotretinoin to see how well they work in treating young patients with neuroblastoma.

OBJECTIVES:

Primary

  • Reduce therapy for patients with intermediate-risk neuroblastoma while maintaining a 3-year overall survival (OS) rate of ≥ 95% by using a response-based duration of therapy algorithm.
  • Maintain an overall 3-year OS rate of ≥ 90% for patients within each group.
  • Utilize loss of heterozygosity, prospectively, at 1p36 and 11q23 to refine risk-stratification and treatment assignment, allowing patients whose tumors lack these chromosomal abnormalities to receive a reduction in therapy, and compare the outcome with patients treated on COG-A3961.
  • Reduce intensity of therapy for patients 365 to < 547 days (12-18 months) of age with stage 4 neuroblastoma and favorable biological features and maintain a 3-year event-free survival (EFS) rate consistent with that for patients < 1 year of age with stage 4 neuroblastoma treated on COG-A3961.
  • Reduce intensity of therapy for patients 365 to < 547 days (12-18 months) of age with stage 3 MYCN-nonamplified but unfavorable histology neuroblastoma and maintain a 3-year EFS rate consistent with that for patients < 1 year of age with stage 3, MYCN-nonamplified, unfavorable histology neuroblastoma treated on COG-A3961.
  • Reduce surgical morbidity for patients with stage 4S neuroblastoma by allowing for biopsy only, rather than complete surgical resection, of the primary tumor.
  • Systematically study the outcome of patients with stage 4S neuroblastoma who are unable to undergo biopsy for biology-based risk assignment.
  • Determine if the extent of surgical resection correlates with the maintenance of local control, EFS and/or OS rates, and surgical complication rate.

Secondary

  • Determine the results of a standard retrieval approach for patients with residual disease after 8 courses of initial therapy.
  • Determine the results of a standard retrieval approach for patients with progressive, nonmetastatic disease.
  • Identify additional biological surrogate markers for disease relapse and/or metastatic progression.
  • Describe the neurologic outcome of patients with paraspinal neuroblastoma primary tumors.
  • Correlate surgical biopsy technique with adequacy of tissue acquisition for biologic studies and with complications associated with the biopsy procedure.
  • Prospectively validate the prognostic ability of the International Neuroblastoma Risk Group image-defined risk factor system, and compare the institutional assessment of image-defined risk factors with that of central review.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 4 treatment groups by risk-stratification based on age, stage (INSS stage 2, 3, 4, or 4S), MYCN status (amplified vs not amplified), histopathologic classification, and tumor DNA index.

  • Initial chemotherapy: Courses of initial chemotherapy are administered every 21 days according to group assignment as outlined below:

    • Course 1: Patients receive carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3.
    • Course 2: Patients receive carboplatin IV over 1 hour, cyclophosphamide IV over 1 hour, and doxorubicin hydrochloride IV over 15 minutes on day 1.
    • Course 3: Patients receive cyclophosphamide IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3.
    • Course 4: Patients receive carboplatin IV over 1 hour and doxorubicin hydrochloride IV over 15 minutes on day 1 and etoposide IV over 1 hour on days 1-3.
    • Course 5: Patients receive cyclophosphamide IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3.
    • Course 6: Patients receive carboplatin IV over 1 hour, cyclophosphamide IV over 1 hour, and doxorubicin hydrochloride IV over 15 minutes on day 1.
    • Course 7: Patients receive carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3.
    • Course 8: Patients receive cyclophosphamide IV over 1 hour and doxorubicin hydrochloride IV over 15 minutes on day 1.

      • Group 1: Patients receive 2 courses of initial chemotherapy. Patients with a partial response (PR) (50-90% reduction in volume) to chemotherapy proceed to observation. Patients without a PR receive 2-6 additional courses of chemotherapy (beginning with course 3). Patients who do not achieve a PR after additional chemotherapy proceed to retrieval chemotherapy.
      • Group 2: Patients receive 4 courses of initial chemotherapy. Patients with a PR after chemotherapy proceed to observation. Patients without a PR receive 2-4 additional courses of chemotherapy (beginning with course 5). Patients who do not achieve a PR after additional chemotherapy proceed to retrieval chemotherapy.
      • Group 3: Patients receive 8 courses of initial chemotherapy. Patients under 12 months of age with stage 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) (> 90% reduction in the volume of the primary tumor and resolution of metastatic disease) to chemotherapy proceed to observation. Patients 12-18 months of age with stage 3 or 4 disease who achieve a VGPR proceed to isotretinoin therapy. Patients who do not achieve a VGPR proceed to retrieval chemotherapy.
      • Group 4: Patients receive 8 courses of initial chemotherapy. If a VGPR cannot be achieved following 8 courses of first-line chemotherapy +/- surgery, then retrieval chemotherapy with cyclophosphamide/topotecan for 2-6 courses is administered until a VGPR can be achieved with a combination of chemotherapy and surgery.
  • Retrieval chemotherapy*: Patients receive cyclophosphamide IV over 30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses.

    • Groups 1 and 2: Patients with a PR after 2-6 courses of retrieval chemotherapy proceed to observation. Patients without a PR after 2-6 courses of retrieval chemotherapy are removed from protocol therapy.
    • Group 3: Patients under 12 months of age with stage 4 disease with a VGPR after retrieval chemotherapy proceed to observation. Patients 12-18 months of age with stage 3 or 4 disease who achieve a VGPR after retrieval chemotherapy proceed to isotretinoin therapy. Patients who do not achieve a VGPR after retrieval chemotherapy are removed from protocol therapy.
    • Group 4: Group 4 patients who fail to achieve a VGPR or who develop progressive, non-metastatic disease within 3 years of study enrollment proceed to isotretinoin therapy. Isotretinoin is also administered to the following Group 4 patients:

      • Age 365 to < 547 days at diagnosis, INSS stage 3, MYCN-NA, unfavorable histology, any ploidy
      • Age 365 to < 547 days at diagnosis, INSS stage 4, MYCN-NA, favorable histology, DI > 1 NOTE: *Patients who have previously received cyclophosphamide and topotecan to achieve first PR/VGPR are not eligible for this Retrieval Therapy.
  • Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished. Reassessment for definitive surgery (for patients who undergo biopsy only or partial resection at diagnosis) is made at the completion of scheduled chemotherapy (after course 2 for group 1, after course 4 for group 2, and after course 8 for groups 3 and 4).
  • Isotretinoin therapy: Beginning 3-4 weeks after completion of chemotherapy or 2 weeks post-operatively (for patients who undergo surgical resection), patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically for up to 10 years.

Data from patients with low-risk disease who are observed following surgical resection only and are not enrolled on ANBL0531, are collected for study objectives.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neuroblastoma
  • Drug: carboplatin
    Given IV
    Other Names:
    • Paraplatin
    • NSC #241240
  • Drug: cyclophosphamide
    Given IV
    Other Names:
    • Cytoxan
    • NSC #26271
  • Drug: doxorubicin hydrochloride
    Given IV
    Other Names:
    • Adriamycin
    • NSC #123127
  • Drug: etoposide
    Given orally
    Other Names:
    • VePesid
    • VP-16
    • NSC #141540
  • Drug: topotecan hydrochloride
    Given IV
    Other Names:
    • SKF-104864
    • Hycamtin
    • NSC #60969
  • Drug: Isotretinoin
    Given orally
    Other Names:
    • 13-cis-retinoic acid
    • RO-43
    • 780
    • Accutane
    • Amnesteem
    • Claravis
    • Sotret
    • NSC#329481
  • Experimental: Group 1 (chemotherapy, surgery)
    2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
    Interventions:
    • Drug: carboplatin
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: topotecan hydrochloride
  • Experimental: Group 2 (chemotherapy, surgery)
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    Interventions:
    • Drug: carboplatin
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: topotecan hydrochloride
  • Experimental: Group 3 (chemotherapy, surgery, antineoplastic therapy)
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    Interventions:
    • Drug: carboplatin
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: topotecan hydrochloride
    • Drug: Isotretinoin
  • Experimental: Group 4 (chemotherapy, surgery, antineoplastic therapy)
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. If a VGPR cannot be achieved following 8 courses of first-line chemo +/- surgery, or progressive, non-metastatic disease develops within 3 years of study enrollment, then patients receive retrieval chemo - cyclophosphamide and topotecan hydrochloride until VGPR can be achieved. Some patients may also undergo surgery and then proceed to isotretinoin therapy.
    Interventions:
    • Drug: carboplatin
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: topotecan hydrochloride
    • Drug: Isotretinoin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
464
Not Provided
June 2014   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/maturing subtype

    • Newly diagnosed disease
    • Intermediate-risk disease
    • Needle biopsies or involved bone marrow are not sufficient for INPC histologic classification
  • Meets 1 of the following criteria:

    • Group 1

      • International Neuroblastoma Staging System (INSS) stage 2A/2B; < 50% resected or biopsy only; ≤ 12 years of age; MYCN-not amplified (NA); any histology and ploidy; normal 1p and 11q
      • INSS stage 3; age < 365 days; MYCN-NA; favorable histology (FH); hyperdiploid (DI) > 1; normal 1p and 11q
      • INSS stage 3; 365 days to 12 years of age; MYCN-NA; FH; normal 1p and 11q
      • INSS stage 4S; age < 365 days; MYCN-NA; FH; DI >1; normal 1p and 11q; clinically symptomatic
    • Group 2

      • INSS stage 2A/2B; < 50% resected or biopsy only; ≤ 12 years of age; MYCN-NA; any histology and ploidy; 1p loss of heterozygosity (LOH) and/or unb11q LOH (or data missing for either)
      • INSS stage 3; age < 365 days; MYCN-NA; FH; DI > 1; 1p LOH and/or unb11q LOH (or data missing for either)
      • INSS stage 3; age < 365 days; MYCN-NA; DI = 1 and/or unfavorable histology (UH); normal 1p and 11q
      • INSS stage 3; 365 days to 12 years of age; MYCN-NA; FH; 1p LOH and/or unb11q LOH (or data missing for either)
      • INSS stage 4; age < 365 days; MYCN-NA; FH; DI > 1; normal 1p and 11q
      • INSS stage 4S; age < 365 days; MYCN-NA; either UH and any ploidy or FH and DI = 1; normal 1p and 11q
      • INSS stage 4S; age < 365 days; MYCN-NA; FH; DI > 1; 1p LOH and/or unb11q LOH (or data missing for either); clinically symptomatic
    • Group 3

      • INSS stage 3; age < 365 days; MYCN-NA; DI = 1 and/or UH; 1p LOH and/or unb11q LOH (or data missing for either)
      • INSS stage 3; age 365 to < 547 days; MYCN-NA; UH; any ploidy; any 1p and 11q
      • INSS stage 4, age < 365 days; MYCN-NA; DI = 1 and/or UH; any 1p and 11q
      • INSS stage 4; age < 365 days; MYCN-NA; FH; DI > 1; 1p LOH and/or unb11q LOH (or data missing for either)
      • INSS stage 4; age 365 to < 547 days; MYCN-NA; FH; DI > 1; any 1p and 11q
      • INSS stage 4S; age < 365 days; MYCN-NA; UH and any ploidy or FH and DI = 1; 1p LOH and/or unb11q LOH (or data missing for either)
      • INSS stage 4S; age < 365 days; unknown or incomplete biologic features
    • Group 4

      • INSS stage 3, age < 365 days, MYCN-NA, either DI = 1 and/or UH, 1p LOH and/or unb11q LOH (or data missing for either)
      • INSS stage 3, age 365 to < 547 days, MYCN-NA, UH, any ploidy, any 1p and 11q 3
      • INSS stage 4, age < 365 days, MYCN-NA either DI = 1 and/or UH, any 1p and 11q
      • INSS stage 4, age < 365 days, MYCN-NA, FH, DI > 1, 1p LOH and/or unb11q LOH (or data missing for either)
      • INSS stage 4, age 365 to < 547 days, MYCN-NA, FH, DI > 1, any 1p and 11q
      • INSS stage 4S, age < 365 days, MYCN-NA, either UH and any ploidy or FH and DI = 1 and 1p LOH and/or unb11q LOH (or data missing for either)
      • INSS stage 4S, age < 365 days, unknown MYCN, histology, and/or ploidy
  • Must already be enrolled on protocol COG-ANBL00B1

    • Simultaneous enrollment on COG-ANBL00B1 and this study allowed for clinical situations in which emergent treatment may be indicated including, but not limited to, the following criteria:

      • Epidural or intraspinal tumors with existing or impending neurologic impairment
      • Periorbital or calvarial-based lesions with existing or impending cranial nerve impairment
      • Anatomic or mechanical compromise of critical organ function by tumor (e.g., abdominal compartment syndrome, urinary obstruction)
      • Asymptomatic but, in the opinion of the treating physician, it is in the patient's best interest to begin chemotherapy immediately due to impending risk of neurologic impairment or organ dysfunction
  • If patient receives study chemotherapy prior to undergoing diagnostic biopsy, the biopsy must be performed within 96 hours of beginning study therapy

    • The only exception to this requirement is for patients with stage 4S disease who are considered too ill to undergo a diagnostic procedure will be waived the requirement for diagnostic tissue submission but will still need to be enrolled on COG-ANBL00B1

      • For patients with stage 4S disease who are very ill and in whom an open biopsy to obtain tissue for diagnosis and biologic studies is considered medically contraindicated, every effort should be made to obtain some tumor tissue by either fine-needle aspiration of a metastatic site of disease and/or sampling of involved bone marrow, so that this tumor sample can be submitted for MYCN determination
  • Patients who require emergent therapy, either prior to the diagnostic biopsy or before biology features are available, can be enrolled simultaneously on COG-ANBL00B1 and COG-ANBL0531 to receive emergent protocol therapy

    • In emergent circumstances, COG-ANBL0531 protocol therapy may be initiated prior to enrollment on study as long as the patient has neuroblastoma by clinical diagnosis, all other COG-ANBL0531 eligibility criteria are met, and the COG-ANBL0531 Initial Therapy consent has been signed prior to starting protocol therapy; in this circumstance ANBL0531 enrollment must occur within 4 working days of starting protocol therapy
    • Clinical situations in which emergent enrollment and treatment may be indicated include, but are not limited to, the following circumstances:

      • Epidural or intraspinal tumors with existing or impending neurologic impairment
      • Periorbital or calvarial-based lesions with existing or impending cranial nerve impairment
      • Anatomic or mechanical compromise of critical organ function by tumor (e.g., abdominal compartment syndrome, urinary obstruction)
      • Evolving hepatomegaly in infants less than 2 months of age

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No other prior chemotherapy or radiotherapy with the exception of dexamethasone
  • No participation in another COG study with tumor therapeutic intent
Both
up to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico
 
NCT00499616
ANBL0531, COG-ANBL0531, CDR0000554708
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Clare Twist, MD Lucile Packard Children's Hospital at Stanford University Medical Center
Study Chair: Mary Lou Schmidt, MD University of Illinois at Chicago
Children's Oncology Group
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP