Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096265
Status:
TERMINATED
Last Update Posted:
2018-03-09
First Post:
2004-11-09
Brief Title:
Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases
Status:
TERMINATED
Status Verified Date:
2018-02
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:
This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to non-small cell lung cancer Radiation therapy uses high-energy x-rays to kill tumor cells Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue Drugs used in chemotherapy such as temozolomide work in different ways to stop tumor cells from dividing so they stop growing or die Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by blocking blood flow to the tumor It is not yet known whether radiation therapy and stereotactic radiosurgery are more effective with or without temozolomide or erlotinib in treating brain metastases
Detailed Description:
PRIMARY OBJECTIVES
I Compare survival in patients with non-small cell lung cancer and brain metastases treated with whole brain radiotherapy and stereotactic radiosurgery with vs without temozolomide or erlotinib
SECONDARY OBJECTIVES
I Compare time to CNS progression in patients treated with these regimens II Compare quality-adjusted survival in patients treated with these regimens III Compare 3-month quality of life in patients treated with these regimens IV Compare the 6-month performance status of patients treated with these regimens
V Compare 6-month steroid dependence in patients treated with these regimens VI Compare cause of death neurologic vs other in patients treated with these regimens
VII Determine the effects of non-protocol chemotherapy in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age and the presence of extracranial metastases 65 years old AND no extracranial metastases vs 65 years old OR extracranial metastases number of metastases 1 vs 2 or 3 and extent of extracranial disease none vs present Patients are randomized to 1 of 3 treatment arms
ARM I Patients undergo whole brain radiotherapy WBRT once daily on days 1-5 8-12 and 15-19 Within 14 days after completion of WBRT patients undergo stereotactic radiosurgery
ARM II Patients undergo WBRT and stereotactic radiosurgery as in arm I Beginning on the first day of WBRT patients receive oral temozolomide once daily on days 1-21 Beginning 4 weeks after completion of WBRT patients may receive oral temozolomide alone once daily on days 1-5 Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
ARM III Patients undergo WBRT and stereotactic radiosurgery as in arm I Beginning on the first day of WBRT patients receive oral erlotinib once daily for up to 6 months
In all arms patients with recurrent brain metastases may undergo additional stereotactic radiosurgery
Quality of life is assessed at baseline and at 3 6 9 12 18 and 24 months
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
I Compare survival in patients with non-small cell lung cancer and brain metastases treated with whole brain radiotherapy and stereotactic radiosurgery with vs without temozolomide or erlotinib
SECONDARY OBJECTIVES
I Compare time to CNS progression in patients treated with these regimens II Compare quality-adjusted survival in patients treated with these regimens III Compare 3-month quality of life in patients treated with these regimens IV Compare the 6-month performance status of patients treated with these regimens
V Compare 6-month steroid dependence in patients treated with these regimens VI Compare cause of death neurologic vs other in patients treated with these regimens
VII Determine the effects of non-protocol chemotherapy in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age and the presence of extracranial metastases 65 years old AND no extracranial metastases vs 65 years old OR extracranial metastases number of metastases 1 vs 2 or 3 and extent of extracranial disease none vs present Patients are randomized to 1 of 3 treatment arms
ARM I Patients undergo whole brain radiotherapy WBRT once daily on days 1-5 8-12 and 15-19 Within 14 days after completion of WBRT patients undergo stereotactic radiosurgery
ARM II Patients undergo WBRT and stereotactic radiosurgery as in arm I Beginning on the first day of WBRT patients receive oral temozolomide once daily on days 1-21 Beginning 4 weeks after completion of WBRT patients may receive oral temozolomide alone once daily on days 1-5 Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
ARM III Patients undergo WBRT and stereotactic radiosurgery as in arm I Beginning on the first day of WBRT patients receive oral erlotinib once daily for up to 6 months
In all arms patients with recurrent brain metastases may undergo additional stereotactic radiosurgery
Quality of life is assessed at baseline and at 3 6 9 12 18 and 24 months
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA021661 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021661 |
| NCI-2009-00720 | REGISTRY | None | None |
| CDR0000389490 | None | None | None |
| RTOG 0320 | None | None | None |
| RTOG 0320 | OTHER | None | None |
| RTOG-0320 | OTHER | None | None |