Stereotactic Body Radiation Therapy (SBRT) as a Boost After Definitive Concurrent Chemoradiation (ChemoRT) for Non-Small Cell Lung Cancer (NSCLC) GCC 0516
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|ClinicalTrials.gov Identifier: NCT00818714|
Recruitment Status : Withdrawn (There was no patient accrual nor study activity due to inability to fund PFTs.)
First Posted : January 8, 2009
Last Update Posted : December 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer (NSCLC)||Radiation: SBRT||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
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
- 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. ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818714
|Principal Investigator:||Anil Dhople, M.D.||University of Maryland, Baltimore|