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Tracking Information | |||||
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First Received Date † | December 11, 2006 | ||||
Last Updated Date | May 7, 2009 | ||||
Start Date † | October 2004 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00410631 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma | ||||
Official Title † | NB2004 Trial Protocol for Risk Adapted Treatment of Children With Neuroblastoma | ||||
Brief Summary | RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether observation is more effective than combination chemotherapy, radiation therapy, and/or autologous stem cell transplant in treating neuroblastoma. PURPOSE: This randomized phase III and phase IV trial is studying observation, combination chemotherapy, radiation therapy, and/or autologous stem cell transplant to compare how well they work in treating young patients with neuroblastoma. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a prospective, historically controlled, randomized, open-label, multicenter study. Patients are stratified according to disease risk (low-risk vs medium-risk vs high-risk).
Patients then proceed to maintenance therapy. NOTE: *Patients under 6 months of age receive up to 4 courses of N4 chemotherapy (as in the low-risk group) instead of N5/N6 chemotherapy until they reach 6 months of age. Patients with active residual tumor after induction chemotherapy undergo external-beam radiotherapy (EBRT) for up to 25 fractions concurrently with maintenance chemotherapy. Secondary surgery for resection of the primary tumor is attempted after course 4 or 6 of the induction therapy and before EBRT.
In both arms, patients with active residual primary tumor after 6 courses of induction therapy undergo iodine I 131 metaiodobenzylguanidine (MIBG)** radiotherapy (before ASCT). Patients also undergo EBRT for up to 25 fractions after ASCT. Secondary surgery for resection of the primary tumor is attempted after course 4 or 6 of induction therapy and before radiotherapy. NOTE: *Patients under 6 months of age receive up to 4 courses of N4 chemotherapy (as in the low-risk group) instead of N5/N6 chemotherapy until they reach 6 months of age. NOTE: **Patients with MIBG-negative disease undergo EBRT only.
NOTE: *Isotretinoin is discontinued during EBRT and restarted 1 week after completion of EBRT. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label | ||||
Condition † | Neuroblastoma | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 642 | ||||
Completion Date | |||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | up to 21 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Germany, Switzerland | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00410631 | ||||
Responsible Party | |||||
Secondary IDs †† | GPOH-NB2004, EU-20661 | ||||
Study Sponsor † | Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | January 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |