Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01781741|
Recruitment Status : Active, not recruiting
First Posted : February 1, 2013
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer||Combination Product: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT) Other: quality-of-life assessment||Early Phase 1|
I. To assess the feasibility/toxicity of combining transcervical extended mediastinal lymphadenectomy (TEMLA) with or without video-assisted thoracoscopic surgery (VATS) and stereotactic body radiation therapy (SBRT).
I. To assess time to initiation of chemotherapy following TEMLA with or without video-assisted thoracoscopic surgery (VATS)and SBRT.
II. To assess feasibility/toxicity of combining TEMLA with or without VATS and SBRT with various chemotherapy regimens (to be determined by medical oncologist based on patient and tumor characteristics).
III. To estimate survival following TEMLA with or without VATS and SBRT. IV. To define any differences in quality of life/toxicity following TEMLA with or without VATS and SBRT based on tumor location (peripheral/central).
V. To assess response for primary tumor control and overall survival in TEMLA only patients.
VI. To assess progression free survival for TEMLA with or without (VATS) patients.
Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without VATS.
After completion of study treatment, patients are followed up at 6,9, and 12 months, every 6 months for 2 years and annually for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Stereotactic Body Radiation Therapy (SBRT) After TEMLA With or Without Minimally Invasive Surgery for Stage III and Stage IV (Oligometastatic) Non-small Cell Lung Cancer|
|Actual Study Start Date :||March 6, 2013|
|Actual Primary Completion Date :||November 30, 2015|
|Estimated Study Completion Date :||July 15, 2018|
Experimental: Treatment (TEMLA and SBRT)
Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without minimally invasive surgery.
Combination Product: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT)
Undergo TEMLA and SBRTOther: quality-of-life assessment
Other Name: quality of life assessment
- Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 3 years ]Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.
- Time until chemotherapy [ Time Frame: From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 5 years ]A 90% confidence interval will be presented.
- Incidence of toxicity associated with combining TEMLA with or without minimally invasive surgery stratified by chemotherapy regimens [ Time Frame: Up to 5 years ]Exact 90% confidence intervals will be obtained for each unique chemotherapy regimen. Will be compared at each time-point between tumor locations using the Fisher's exact test.
- Overall survival [ Time Frame: From SBRT completion until death, assessed up to 5 years ]Will be described using standard Kaplan-Meier methodologies. The median survival time, 3-year survival rate, and 5-year survival rate and will be estimated and presented with 90% confidence intervals.
- Quality of life (QoL) scores from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ Lung Cancer-Specific Module [ Time Frame: Up to 5 years ]Will be compared with cumulative toxicity rates at each time-point between tumor locations using the Mann-Whitney U test. Comparisons of QoL scores between time-points will be made using the Wilcoxon signed rank test.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781741
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Anurag Singh||Roswell Park Cancer Institute|