Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01657617
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2012-01-17
Brief Title:
Stereotactic Body Radiation Therapy in Stage IIIII Non Small Cell Lung Cancer
Sponsor:
Ronald McGarry
Organization:
University of Kentucky
Study Overview
Official Title:
Stereotactic Body Radiation Therapy for Post-chemoradiation Residual Disease in Stage IIIII Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2018-09
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:
It is apparent that local control for Non-small Cell Lung Cancer NSCLC remains a significant problem Conventional radiation therapy techniques have limitations for the dose that can be delivered to a chest tumor mass due to the adjacent dose limiting organs Mounting evidence supports the use of hypofractionated stereotactically delivered radiation therapy to control lung cancer with acceptable toxicity profiles
Thus the investigators propose to increase the doses of radiation to residual masses of NSCL to a BED 100 Gy by the addition of two fractions of stereotactically delivered boost radiation therapy to residual disease post-conventional chemoradiation to at least 594 Gy in 180 cGy fractions Using the linear quadratic equation to model doses of radiation therapy 594 Gy would have a BED of approximately 70 Gy Single fraction stereotactic body radiation therapy SBRT of 10 Gy would have a BED of approximately 20 Gy Thus the addition of two fractions of 10Gy of SBRT to limited volumes of PET residual disease would theoretically result in higher degrees of local control of lung cancer masses achieving a minimum cumulative BED of approximately 110Gy-equivalent
Thus the investigators propose to increase the doses of radiation to residual masses of NSCL to a BED 100 Gy by the addition of two fractions of stereotactically delivered boost radiation therapy to residual disease post-conventional chemoradiation to at least 594 Gy in 180 cGy fractions Using the linear quadratic equation to model doses of radiation therapy 594 Gy would have a BED of approximately 70 Gy Single fraction stereotactic body radiation therapy SBRT of 10 Gy would have a BED of approximately 20 Gy Thus the addition of two fractions of 10Gy of SBRT to limited volumes of PET residual disease would theoretically result in higher degrees of local control of lung cancer masses achieving a minimum cumulative BED of approximately 110Gy-equivalent
Detailed Description:
Lung cancer represents one of the most challenging malignancies to manage Cure rates have only marginally improved in the last 20 years It is the most commonly fatal cancer in both men and women with overall 5 year survivals of 15 Lung cancer kills more Americans than the next three most common malignancies combined
Most non small cell lung cancer NSCLC presents at advanced stages Only approximately 25 present with stage III disease 40 with stage III and 35 patients present with stage IV 1 The optimal treatment of stage IIIII NSCLC is complex For those patients who are surgical candidates and a complete resection is technically feasible radical surgery remains the standard of care Traditionally those patients with multiple N2 nodal levels or T4 disease are considered inoperable Given that the average age of patients diagnosed with NSCLC is in their mid-60s and usually have long smoking histories many patients are medically inoperable
Most non small cell lung cancer NSCLC presents at advanced stages Only approximately 25 present with stage III disease 40 with stage III and 35 patients present with stage IV 1 The optimal treatment of stage IIIII NSCLC is complex For those patients who are surgical candidates and a complete resection is technically feasible radical surgery remains the standard of care Traditionally those patients with multiple N2 nodal levels or T4 disease are considered inoperable Given that the average age of patients diagnosed with NSCLC is in their mid-60s and usually have long smoking histories many patients are medically inoperable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None