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Sponsored by: |
University of Maryland |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00818714 |
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 | Intervention | Phase |
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Non-Small Cell Lung Cancer (NSCLC) |
Radiation: SBRT |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 35 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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Radiation: SBRT
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC stage III based on only one of the following combinations of TNM staging:
Pretreatment Evaluations Required for Eligibility include:
Mandatory staging studies: Must be done within 21 days prior to study entry
CBC with differential, platelet count, Comprehensive metabolic panel including: electrolytes, Albumin, TBilirubin, Calcium, Cl, CO2, Creatinine, Glucose, K, TProtein, Na, BUN, AlkPhos, AST, ALT, Magnesium.
Pre-treatment laboratory values must be as follows:
WBC count: < or = 2.5 x institutional ULN; Absolute granulocyte count: > or = 1,500/mm3 Platelets: > or = 100,000/mm3 Total bilirubin: < or = 1.5 x institutional ULN Serum creatinine: < or = 1.5x institutional ULN AST and ALT: < or = 2.5 x institutional ULN Serum albumin: > or = 3.0 g/dL
Exclusion Criteria:
1 Patients with primary tumors > 5 cm or involving the central chest and structures of the mediastinum after their definitive course of chemoradiation.
2. The primary tumor of any T-stage within or touching the zone of the proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi.
Contact: Anil Dhople, M.D. | 410 328 2325 | adhople@umm.edu |
Contact: Nancy Kennedy, RN BSN | 410 328 2513 | nkennedy@um.edu |
United States, Maryland | |
University of Maryland Baltimore | |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: | Anil Dhople, M.D. | University of Maryland |
Responsible Party: | University of Maryland Baltimore ( Anil Dhople, M.D. Assistant Professor ) |
Study ID Numbers: | H-26850, GCC 0516 |
Study First Received: | January 7, 2009 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00818714 |
Health Authority: | United States: Institutional Review Board |
IIIA, selected IIIB (T1N2-3M0, T2N2-3M0, T3N1-3M0) |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |