Status:
UNKNOWN
Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma
Lead Sponsor:
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
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 ...
Detailed Description
OBJECTIVES: Primary * Determine the event-free survival (EFS) of younger patients with newly diagnosed neuroblastoma categorized in the low-risk group (LRG) who undergo observation only or receive c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of neuroblastoma by histology using tumor tissue or as evidenced by the presence of distinct neuroblastoma cells in the bone marrow AND elevated catecholamine metabolites (i.e., homovanillic acid \[HVA\] and vanillylmandelic acid \[VMA\]) in blood or urine
- Newly diagnosed disease (for patients in the low-risk group)
- Diagnosis from tumor tissue (for patients in the medium-risk group)
- Meets criteria for 1 of the following risk groups:
- Low-risk group
- No MYCN amplification AND meets 1 of the following criteria:
- Stage 1 disease
- Stage 2 disease with no chromosome 1p deletion or imbalance
- Stage 3 disease with no chromosome 1p deletion or imbalance (for patients \< 2 years of age)
- Stage 4S disease (for patients \< 1 year of age)
- Medium-risk group
- No MYCN amplification AND meets 1 of the following criteria:
- Stage 2 disease with chromosome 1p deletion or imbalance
- Stage 3 disease with chromosome 1p deletion or imbalance
- Any chromosome 1p status (for patients ≥ 2 years of age)
- Stage 4 disease (for patients \< 1 year of age)
- High-risk group, meeting 1 of the following criteria:
- Any stage disease with MYCN amplification
- Any MYCN status (for patients ≥ 1 year of age)
- PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- No prior nephrectomy or other mutilating surgery as initial surgery (for patients in the low-risk group)
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
642 Patients enrolled
Trial Details
Trial ID
NCT00410631
Start Date
October 1 2004
Last Update
August 7 2013
Active Locations (80)
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1
Kinderklinik - Universitaetsklinikum Aachen
Aachen, Germany, D-52074
2
Klinikum Augsburg
Augsburg, Germany, DOH-86156
3
Klinikum am Bamberg
Bamberg, Germany, 96049
4
Klinikum Bayreuth
Bayreuth, Germany, D-95445