An early phase II study of delayed local treatment with surgery and radiation, that follows high dose chemotherapy with peripheral blood stem cell transplantation in patients with advanced neuroblastoma
- Conditions
- euroblastoma
- Registration Number
- JPRN-UMIN000000973
- Lead Sponsor
- Japan Neuroblastoma Study Group
- Brief Summary
Background: The progression-free survival rates of high risk neuroblastoma (HR-NB) patients are still unacceptable. The Japan Neuroblastoma Study Group (JNBSG) has examined the feasibility of time-intensive multimodal treatment with delayed local control treatment (DLCT). Methods: Between June 2006 and February 2008, 11 patients, four male and seven female, with newly diagnosed HR-NB patients were enrolled in the study. The median age at diagnosis was 22 months (range, 13 to 66 months). DLCT consisted of induction chemotherapy (IC) with cisplatin (100mg/m2), pirarubicin (40mg/m2), vincristine (1.5mg/m2), and cyclophosphamide (2,400mg/m2). After 5 courses of IC, all patients were treated immediately with myeloablative chemotherapy with carboplatin (1,600mg/m2), etoposide (800mg/m2), and melphalan (200mg/m2). After these treatments, local tumor eradication with surgery and irradiation (21Gy) was performed. Results: DLCT was completed in 4 patients, while it was discontinued in the remaining 7 patients due to progressive disease (PD) or regimen related toxicity (RRT). Six patients died due to PD (n=4) or RRT (n=2), and 5 patients were alive at the time of evaluation. Conclusions: These results suggest that DLCT is feasible in terms of completion. Based on the results of the study, we designed a phase II study that will be conducted by the JNBSG.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
Active double cancer; pregnant or possiblly pregnant women and those during breast feeding; patients with psychologic disease or symptoms who have difficulty in receiving protocol treatment; patients with disease that may interfere with the protocol treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year progression-free survival rate from the 12th week of the protocol
- Secondary Outcome Measures
Name Time Method 2-year progression-free and overall survival rates, clinical response rate at the 12th week of the protocol and that before surgery, the incidence of adverse events