Stereotactic Body Radiation Therapy (SBRT) as a Boost After Definitive Concurrent Chemoradiation (ChemoRT) for Non-Small Cell Lung Cancer (NSCLC) GCC 0516
SBRT to deliver a boost dose to residual primary tumor after definitive doses of standard EBRT have been delivered concurrently with chemotherapy.
Serum levels of TGF-Beta1 and correlation with SBRT toxicity.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||0516 GCC: Stereotactic Body Radiation Therapy As A Boost After Definitive Treatment With Concurrent Chemoradiation In Patients With Non-Small Cell Lung Cancer|
- To determine the toxicity profile in the context of dose escalation of stereotactic body radiation therapy (SBRT) after definitive therapy with concurrent chemoradiation and to define the maximum tolerated dose. [ Time Frame: Follow-up Post-SBRT: 2, 4, 6,12 weeks, every 3 months for 2 years, every 6 months for 2 years, then at the discretion of the treating M.D. ] [ Designated as safety issue: Yes ]
- To study the incidence of the radiation toxicity, pneumonitis in patients treated with SBRT by serially following TGF-Beta1 levels. [ Time Frame: Prestudy thru post SBRT week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Dose escalation study to define the maximum tolerated boost dose of stereotactic body radiation therapy (SBRT) to the residual primary tumor after definitive therapy with concurrent chemotherapy and external beam radiation.
SBRT x 3 (start 6-9 weeks following standard ChemoRT; Time between SBRT Boost treatments: 40 hours to 8 days)
Dose Escalation Schema:
Cohort -3: 4 Gy x3 Cohort -2: 5 Gy x3 Cohort -1: 6 Gy x3 If de-escalation is required after initial cohort
Cohort 1: 7 Gy x 3 INITIAL COHORT Cohort 2: 8 Gy x 3 Cohort 3: 9 Gy x 3
Continue +1 Gy x 3 until reach MTD
This protocol is designed to use stereotactic body radiation therapy (SBRT) to deliver a boost dose to residual primary tumor after definitive doses of standard external beam radiation have been delivered concurrently with chemotherapy. It is designed to determine the toxicity profile(side effects) in the context of dose escalation of stereotactic body radiation therapy (SBRT) after definitive therapy with concurrent chemoradiation and to define the maximum tolerated dose.
Serum levels of TGF-Beta1 have been demonstrated to correlate with the incidence of the radiation toxicity, pneumonitis in patients treated with standard external beam radiation. This study will serially follow TGF-Beta1 levels in patients to see if the same correlation exists with SBRT toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818714
|Principal Investigator:||Anil Dhople, M.D.||University of Maryland, Baltimore County|