Clinical trial · Interventional
Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma
PHASE III MULTICENTRE TRIAL OF TREATMENT OF NEUROBLASTOMA IN CHILDREN AND ADOLESCENTS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is most effective in treating patients with different stages of and risk factors for neuroblastoma. PURPOSE: Phase III trial to study the effectiveness of therapy based on stage of disease and risk assessment in treating children with neuroblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (17)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Neuroblastoma with diagnosis based on one of the following: Histologic confirmation Cytologic confirmation in bone marrow and elevated catecholamine metabolites Typical tumor appearance on CT, MRI, or ultrasound and: Unequivocal MIBG uptake in tumor Elevated catecholamines in serum or urine No primitive neuroectodermal tumor or primary intracerebral neuroblastoma Such patients referred to protocol GER-HIT90 PATIENT CHARACTERISTICS: Age: Under 21 Other: No serious cerebral trouble No severe concomitant disease, e.g.: No severe congenital malformation No severe organ function abnormality PRIOR CONCURRENT THERAPY: No prior cytostatic therapy (e.g., for Wilms' tumor) No concurrent therapy
References
Publications (7)
- BACKGROUNDKrams M, Hero B, Berthold F, Parwaresch R, Harms D, Rudolph P. Proliferation marker KI-S5 discriminates between favorable and adverse prognosis in advanced stages of neuroblastoma with and without MYCN amplification. Cancer. 2002 Feb 1;94(3):854-61. PMID 11857322
- BACKGROUNDSimon T, Hero B, Dupuis W, Selle B, Berthold F. The incidence of hearing impairment after successful treatment of neuroblastoma. Klin Padiatr. 2002 Jul-Aug;214(4):149-52. doi: 10.1055/s-2002-33179. PMID 12165893
- BACKGROUNDBerthold F, Hero B, Kremens B, Handgretinger R, Henze G, Schilling FH, Schrappe M, Simon T, Spix C. Long-term results and risk profiles of patients in five consecutive trials (1979-1997) with stage 4 neuroblastoma over 1 year of age. Cancer Lett. 2003 Jul 18;197(1-2):11-7. doi: 10.1016/s0304-3835(03)00076-4. PMID 12880954
- BACKGROUNDvon Schweinitz D, Hero B, Berthold F. The impact of surgical radicality on outcome in childhood neuroblastoma. Eur J Pediatr Surg. 2002 Dec;12(6):402-9. doi: 10.1055/s-2002-36952. PMID 12548494
- RESULTSimon T, Hero B, Hunneman DH, Berthold F. Tumour markers are poor predictors for relapse or progression in neuroblastoma. Eur J Cancer. 2003 Sep;39(13):1899-903. doi: 10.1016/s0959-8049(03)00376-9. PMID 12932669
- RESULTHaberle B, Hero B, Berthold F, von Schweinitz D. Characteristics and outcome of thoracic neuroblastoma. Eur J Pediatr Surg. 2002 Jun;12(3):145-50. doi: 10.1055/s-2002-32721. PMID 12101494
- RESULTHero B, Hunneman DH, Gahr M, Berthold F. Evaluation of catecholamine metabolites, mIBG scan, and bone marrow cytology as response markers in stage 4 neuroblastoma. Med Pediatr Oncol. 2001 Jan;36(1):220-3. doi: 10.1002/1096-911X(20010101)36:13.0.CO;2-6. PMID 11464889