STEREOtactic Radiation and Chemotherapy in Lung Cancer (STEREO) (STEREO)
|Non-small Cell Lung Cancer (NSCLC)||Radiation: Stereotactic Body Radiation Therapy|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||STEREOtactic Radiation and Adjuvant Chemotherapy in Lung Cancer (STEREO)|
- To measure the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC) [ Time Frame: 3 years after subject enrollment ]
- Survival rate, specifically disease-free survival (DFS) and overall survival (OS), measured by follow-up visits and tests [ Time Frame: 3 years after subject enrollment ]
- safety of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC) measured by adverse events [ Time Frame: 3 years after subject enrollment ]
- quality of life (QOL) measured by subject questionnaires [ Time Frame: 3 years after subject enrollment ]
- Measurement of biological and clinical markers for toxicity, DFS, and OS [ Time Frame: 3 years after subject enrollment ]
|Study Start Date:||February 2011|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: All subjects
Subjects will receive chemotherapy after stereotactic body radiation therapy.
Radiation: Stereotactic Body Radiation Therapy
12 Gray (Gy) x 4 fractions (48 Gy) will be delivered to peripherally located tumors (> 2 cm in all directions around the proximal bronchial tree and centrally located tumors (within <2 centimeters (cm) of proximal bronchial tree). Treatment should be given on consecutive days. There will be 4 or 5 treatments.
This study evaluates the effect of adjuvant chemotherapy in patients who received treatment with stereotactic radiation for early stage lung cancer and who are at high risk for microscopic metastatic disease.
Chemotherapy in the form of cisplatin/docetaxel or cisplatin/pemetrexed will be administered approximately six weeks after Stereotactic Body Radiation Therapy (SBRT). Patients will then undergo follow up clinical evaluation and imaging to evaluate treatment response and for surveillance.
A patient population of 65 patients will be required. Enrollment in this protocol is planned by multi center involvement in the state of Kentucky as part of the Kentucky Trial Network (KTN).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300299
|United States, Kentucky|
|James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Goetz H Kloecker, MD||James Graham Brown Cancer Center|