Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Treatment||stereotactic body radiation therapy|
|Sponsor||Roswell Park Cancer Institute|
|Start date||September 2008|
|End date||April 2020|
|Trial size||98 participants|
|Trial identifier||NCT00843726, I 124407|
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||parallel assignment|
Incidence of RTOG grade 3 or higher toxicity
time frame: 1year
time frame: 5 years
Correlation between blood and serum markers and survival and toxicity
time frame: 4 years
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Node-negative disease - Peripheral disease - T1-T3, N0 disease measuring ≤ 5 cm - No T2-T3 tumors > 5 cm or T3 tumor based on chest wall involvement - Surgically resectable primary disease, but patient refuses surgery or is deemed to be medically inoperable - No metastatic disease - No tumor within the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions PATIENT CHARACTERISTICS: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly) PRIOR CONCURRENT THERAPY: - No prior thoracic radiotherapy
|Official title||A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer|
|Principal investigator||Anurag K. Singh, MD|
|Description||OBJECTIVES: Primary - To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer. Secondary - To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens. - To correlate outcomes and toxicities with imaging and patient and tumor biomarkers. OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). - Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting. After completion of study treatment, patients are followed for 5 years.|
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