Combination Chemotherapy and Surgery With or Without Radiation Therapy in Treating Patients With Stage 2 or Stage 3 Neuroblastoma

NCT00416676 | Unknown Phase 3

• 3 other identifiers: CCLG-NB-1993-01CDR0000454571EU-20594
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as vincristine, cyclophosphamide, cisplatin, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase III trial is studying how well giving combination chemotherapy and surgery with or without radiation therapy works in treating patients with stage 2 or stage 3 neuroblastoma.

Conditions

Neuroblastoma

Keywords

localized resectable neuroblastoma; localized unresectable neuroblastoma; regional neuroblastoma

Interventions

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

etoposide DRUG

vincristine sulfate DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed neuroblastoma * Stage 2B or 3 disease * Must be able to undergo radical radiotherapy * Radiotherapy contra-indicated if disease site is near a critical organ (e.g., mass overlying a single functioning kidney or the size of the residual tumor after chemotherapy precludes delivery of the specified radiation dose) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

MeSH Terms

Conditions

Neuroblastoma

Interventions

Carboplatin; Cisplatin; Cyclophosphamide; Etoposide; Vincristine; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Ann Barrett

  University of Glasgow

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Last Updated: August 2, 2013

Record last verified: 2006-12