Surgery in Treating Children With Neuroblastoma
- Conditions
- Neuroblastoma
- Interventions
- Procedure: conventional surgeryBiological: filgrastimRadiation: radiation therapyBiological: sargramostimProcedure: adjuvant therapy
- Registration Number
- NCT00003119
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma.
PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.
- Detailed Description
OBJECTIVES:
* To determine if asymptomatic patients with low-risk neuroblastoma treated with surgery alone will have a 3-year survival rate of 95%.
* Estimate the response and 3-year event-free survival rates of symptomatic patients treated with chemotherapy.
* Estimate the event-free survival and overall survival rates in patients who relapse or progress after initial treatment with surgery alone.
* Determine the acute and chronic toxic effects associated with treating low-risk neuroblastoma with surgery alone or surgery and chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage, MYCN status, age, and histology.
Patients undergo primary tumor resection and biopsy of regional nodes. Patients with at least 50% of the tumor resected are followed monthly for 3 months, every 3 months for 9 months, every 6 months for one year, and then annually thereafter.
Regimen I
* Patients with clinically symptomatic (e.g., respiratory distress, spinal cord compromise with or without neurologic deficit, inferior vena cava compression with renal or bowel ischemia, intractable vomiting due to gastrointestinal obstruction, genitourinary obstruction, or coagulopathy) low-risk neuroblastoma or who have less than 50% of the primary tumor resected receive 4 different courses of chemotherapy.
* Course 1: Patients receive carboplatin IV over 1 hour followed by etoposide IV over 2 hours on day 0 and etoposide only on days 1 and 2.
* Course 2: Patients receive carboplatin IV over 1 hour, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-60 minutes on day 1.
* Course 3: Patients receive cyclophosphamide IV over 1 hour followed by etoposide IV over 2 hours on day 0 and etoposide only on days 1 and 2.
* Course 4: Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours followed by doxorubicin IV over 15-60 minutes on day 0 and etoposide only on days 1 and 2.
Regimen II
* Patients who progress to or recur with unfavorable biology intermediate-risk disease receive an additional 4 courses of chemotherapy.
* Course 5: Patients receive treatment as in course 3 above.
* Course 6: Patients receive treatment as in course 2 above.
* Course 7: Patients receive treatment as in course 1 above.
* Course 8: Patients receive cyclophosphamide IV over 1 hour followed by doxorubicin IV over 15-60 minutes on day 1.
All infants under 60 days of age receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 to 36 hours after chemotherapy and continuing until blood counts recover.
Courses in both regimens repeat every 3 weeks in the absence of unacceptable toxicity.
Patients at risk for symptomatic spinal cord compression may also receive chemotherapy. Patients experiencing progressive or recurrent disease after observation undergo repeat surgery and/or chemotherapy as above. Patients with clinically symptomatic disease may also undergo radiotherapy if response to chemotherapy is not rapid.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 968
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment 1 - Asymptomatic - no immediate chemotherapy conventional surgery - Treatment 1 - Asymptomatic - no immediate chemotherapy radiation therapy - Symptomatic - immediate chemotherapy filgrastim - Symptomatic - immediate chemotherapy sargramostim - Symptomatic - immediate chemotherapy carboplatin - Symptomatic - immediate chemotherapy cyclophosphamide - Symptomatic - immediate chemotherapy doxorubicin hydrochloride - Symptomatic - immediate chemotherapy adjuvant therapy - Symptomatic - immediate chemotherapy conventional surgery - Symptomatic - immediate chemotherapy radiation therapy - Symptomatic - immediate chemotherapy etoposide -
- Primary Outcome Measures
Name Time Method Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone The primary objective is to estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone. Under the assumption that about 90% of the low risk 2A/2B patients will be asymptomatic, and 10% of these will be lost to follow up, the projected sample size will enable estimation of the survival rate with a standard error less than .03. This sample size will also provide sufficient power for the sequential monitoring plan (see below) for this subgroup of patients.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (234)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of South Alabama Cancer Research Institute
🇺🇸Mobile, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Scroll for more (224 remaining)University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States