Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003119
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
1999-11-01
Brief Title:
Surgery in Treating Children With Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma A Pediatric Oncology GroupChildrens Cancer Group Intergroup Study
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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 andor 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
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 eg 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000065874 | OTHER | Clinical Trialsgov | None |
| COG-P9641 | OTHER | None | None |
| POG-P9641 | OTHER | None | None |
| CCG-P9641 | OTHER | None | None |