Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003278
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
1999-11-01
Brief Title:
Radiation Therapy and High-Dose Corticosteroids in Treating Older Patients With Primary CNS Non-Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Primary Central Nervous System Non-Hodgkinss Lymphoma PCNSL A Phase II Clinical Trial of Radiation Therapy and High Dose Corticosteroids for Elderly Patients 70 Years of Age and Older
Status:
COMPLETED
Status Verified Date:
2016-07
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy with a corticosteroid such as dexamethasone may be an effective treatment for non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of radiation therapy and high-dose dexamethasone in treating older patients with primary CNS non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of radiation therapy and high-dose dexamethasone in treating older patients with primary CNS non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Assess the effectiveness of high-dose dexamethasone after whole-brain radiotherapy in maintaining response and preventing recurrence in elderly patients with primary central nervous system non-Hodgkins lymphoma
Assess the toxic effects of this regimen in these patients
Assess the survival rate of patients after this regimen
Identify the anatomic rates of recurrence and frequency of systemic involvement in patients treated with this regimen
Identify the factors that appear to be associated with outcome in patients treated with this regimen
OUTLINE Patients undergo whole-brain radiotherapy WBRT daily 5 days a week for 45 weeks Beginning 30 days after WBRT is completed patients receive high-dose dexamethasone IV on days 1-5 during course 1 and on day 1 only during all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month after radiotherapy every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 28 patients will be accrued for this study within 6 years
Assess the effectiveness of high-dose dexamethasone after whole-brain radiotherapy in maintaining response and preventing recurrence in elderly patients with primary central nervous system non-Hodgkins lymphoma
Assess the toxic effects of this regimen in these patients
Assess the survival rate of patients after this regimen
Identify the anatomic rates of recurrence and frequency of systemic involvement in patients treated with this regimen
Identify the factors that appear to be associated with outcome in patients treated with this regimen
OUTLINE Patients undergo whole-brain radiotherapy WBRT daily 5 days a week for 45 weeks Beginning 30 days after WBRT is completed patients receive high-dose dexamethasone IV on days 1-5 during course 1 and on day 1 only during all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month after radiotherapy every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 28 patients will be accrued for this study within 6 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 |
|---|---|---|---|
| CDR0000066184 | REGISTRY | PDQ Physician Data Query | None |