Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489008
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2007-06-20
Brief Title:
SRS Study in Patients With Non-Small Cell Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Stereotactic Body Radiotherapy for Stage I T1-T2 N0 M0 Selective Stage II Chest Wall T3 N0M0 or Isolated Peripheral Lung Recurrent Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2020-03
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:
The goal of this clinical research study is to learn if stereotactic body radiotherapy SBRT can help to control NSCLC The safety of SBRT will also be studied
Objectives
To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy SBRT for patients with medically inoperable stage I T1-2 N0M0 selective stage II chest wall T3 N0M0 or isolated peripheral lung recurrent non-small cell lung cancer NSCLC
Primary goal Improve 2 years progression free survival at the treated primary tumor site
Secondary goals
1 Improve disease free survival disease specific survival and overall survival at 2 years
2 Decrease grade 3 and above acute andor chronic toxicities
3 Collect blood for future biomarkers study
Objectives
To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy SBRT for patients with medically inoperable stage I T1-2 N0M0 selective stage II chest wall T3 N0M0 or isolated peripheral lung recurrent non-small cell lung cancer NSCLC
Primary goal Improve 2 years progression free survival at the treated primary tumor site
Secondary goals
1 Improve disease free survival disease specific survival and overall survival at 2 years
2 Decrease grade 3 and above acute andor chronic toxicities
3 Collect blood for future biomarkers study
Detailed Description:
Stereotactic body radiotherapy is designed to provide an image guided more focused dose escalated radiotherapy over a shorter time frame 1 week rather than 7 weeks than conventional radiation therapy The goal of SBRT is to improve tumor control while reducing the side effects
If you are found to be eligible to take part in this study you will receive daily SBRT for 4 days in a row over a 45 minute time period During the treatment you will lie still on a table for about 45 minutes per day in the same position The machine will deliver the dose according to the plan developed by the doctor and the dose will be controlled by a computer
During the treatment you will be seen by a doctor and research nurse once a week to evaluate possible side effects A physical exam and a medical history will be done at these visits
You will be taken off study early if the disease gets worse or intolerable side effects occur
You will have a follow-up visit 6 weeks after completion of radiotherapy to check for side effects You will continue to have follow-up visits that will decrease in frequency over time You will have imaging tests chest CT or positron emission computed tomography PET scan and routine blood tests about 2 teaspoons at these follow-up visits
This is an investigational study SBRT is FDA approved for the treatment of lung cancer About 138 patients will take part in this study All will be enrolled at MD Anderson
If you are found to be eligible to take part in this study you will receive daily SBRT for 4 days in a row over a 45 minute time period During the treatment you will lie still on a table for about 45 minutes per day in the same position The machine will deliver the dose according to the plan developed by the doctor and the dose will be controlled by a computer
During the treatment you will be seen by a doctor and research nurse once a week to evaluate possible side effects A physical exam and a medical history will be done at these visits
You will be taken off study early if the disease gets worse or intolerable side effects occur
You will have a follow-up visit 6 weeks after completion of radiotherapy to check for side effects You will continue to have follow-up visits that will decrease in frequency over time You will have imaging tests chest CT or positron emission computed tomography PET scan and routine blood tests about 2 teaspoons at these follow-up visits
This is an investigational study SBRT is FDA approved for the treatment of lung cancer About 138 patients will take part in this study All will be enrolled at MD Anderson
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 |
|---|---|---|---|
| NCI-2012-01495 | REGISTRY | NCI CTRP | None |