NCT00276731

Combination Chemotherapy Followed By Surgery With or Without Radiation Therapy in Treating Young Patients With Stage II or Stage III Neuroblastoma

Randomized Study of Radiotherapy in Patients With Stage 2B/3 (INSS) Neuroblastoma in Children Over 1 Year of Age

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Children's Cancer and Leukaemia Group · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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 more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain. It is not yet know whether combination chemotherapy followed by surgery alone is more effective than combination chemotherapy followed by surgery and radiation therapy in treating neuroblastoma. PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by surgery to see how well it works compared to combination chemotherapy followed by surgery and radiation therapy in treating young patients with stage II or stage III neuroblastoma.

Detailed description

OBJECTIVES: * Compare the local control and event-free and overall survival of young patients with stage IIB and III neuroblastoma treated with neoadjuvant combination chemotherapy followed by surgery with vs without radiotherapy. * Determine the toxic effects of these regimen in these patients. OUTLINE: This is a multicenter, randomized study. * Induction combination chemotherapy: Patients receive vincristine IV and cyclophosphamide IV on day 1. Patients also receive cisplatin IV continuously over 24 hours on day 1 and etoposide IV over 4 hours on day 2 during courses 1, 3, and 5 and carboplatin IV over 1 hour and etoposide IV over 4 hours on day 1 during courses 2 and 4. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to surgery unless complete resection was done during initial staging and complete response was maintained. * Surgery: Patients undergo biopsy or surgical resection of the tumor 2-3 weeks after completion of induction combination chemotherapy. * Post-surgical treatment: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive two additional courses of combination chemotherapy comprising vincristine, cisplatin, etoposide, and cyclophosphamide in course 6 and vincristine, carboplatin, etoposide, and cyclophosphamide in course 7. * Arm II: Patients undergo radiotherapy 2-4 weeks after surgery. Beginning 3 weeks after completion of radiotherapy, patients receive chemotherapy as in arm I After completion of study treatment, patients are evaluated periodically. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	cisplatin
DRUG	cyclophosphamide
DRUG	etoposide
DRUG	vincristine sulfate
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy
RADIATION	radiation therapy

Timeline

• Start date: 1995-03-01
• First posted: 2006-01-13
• Last updated: 2013-09-17

Locations

22 sites across 2 countries: Ireland, United Kingdom