Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-03-02 @ 4:10 AM
Study NCT ID:
NCT02568033
Status:
UNKNOWN
Last Update Posted:
2017-01-31
First Post:
2015-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer
Sponsor:
The Cooper Health System
Organization:
Study Overview
Official Title:
Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer (Protocol Number GK001)
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
RECRUITING
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 is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy to treat stage II and III lung cancer that is not amendable to surgical resection.
Detailed Description:
Current standard of care for treatment of locally advanced (unresectable stage II and all of stage III) non-small cell lung cancer (NSCLC) is chemo-radiation which consists of 7 weeks of radiation and chemotherapy given at a reduced dose (as opposed to systemic dose when chemotherapy given by itself). While outcomes have improved over time they remain humbling, with current approaches associated with overall poor results both in terms of local (30% of patients have local failure) and distant control (40% of patients have distant failure) with a median overall survival of 17 months.
This study is evaluating treatment with full dose chemotherapy and stereotactic body radiotherapy (SBRT). SBRT uses high doses of radiation in a very precise and conformal manner, the number of treatments are much reduced versus conventional radiation (SBRT would be able to be completed in 2 weeks or less). The biologically effective dose of SBRT is much higher than that of conventional radiation; despite being a shorter number of treatments the effective radiation dose is higher. SBRT would be completed in 2 weeks and since radiation would be completed in a shorter time span, would allow patients to have higher (systemic) chemotherapy doses.
The purpose of this study is to explore SBRT in addition to systemic doses of chemotherapy in the treatment of locally advanced NSCLC.
This study is evaluating treatment with full dose chemotherapy and stereotactic body radiotherapy (SBRT). SBRT uses high doses of radiation in a very precise and conformal manner, the number of treatments are much reduced versus conventional radiation (SBRT would be able to be completed in 2 weeks or less). The biologically effective dose of SBRT is much higher than that of conventional radiation; despite being a shorter number of treatments the effective radiation dose is higher. SBRT would be completed in 2 weeks and since radiation would be completed in a shorter time span, would allow patients to have higher (systemic) chemotherapy doses.
The purpose of this study is to explore SBRT in addition to systemic doses of chemotherapy in the treatment of locally advanced NSCLC.
Study Oversight
Has Oversight DMC:
False
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?: