Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer (RAXSIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03431415|
Recruitment Status : Withdrawn (Accrual issues)
First Posted : February 13, 2018
Last Update Posted : August 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Stage I Surgery Stereotactic Body Radiation Therapy||Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy Radiation: Stereotactic Body Radiation Therapy||Not Applicable|
Today, the best medical literature available confirms that surgery is superior to radiation therapy in the treatment of the early stage lung cancer. However, good emerging data demonstrates potential equality between these two treatments. Two major international studies have tried to compare both treatments but have failed to complete the study because of the lack of patients accrual. We chose to design a trial in which patients will be part of a shared decision making process in selecting the treatment modality.
Patients with early stage lung cancer, that can undergo surgical treatment will be offered SBRT, and in conjunction with the pulmonologist will decide which treatment they prefer. We intend to complete the recruitment of patients within 02 years, then follow-up for 5 more years to collect data.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer|
|Actual Study Start Date :||January 28, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||February 2025|
Active Comparator: Surgery
Patients that will undergo surgery (anatomical segmentectomy, lobectomy or bilobectomy) as primary lung cancer treatment
Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy
Lung Cancer Anatomical Resection
Active Comparator: SBRT (Stereotactic Body Radiation Therapy)
Patients that will undergo SBRT as primary lung cancer treatment
Radiation: Stereotactic Body Radiation Therapy
SBRT treatment. 48Gy in 4 sessions for peripheral lesions and 50Gy in 5 sessions for central lesions.
- Disease free survival [ Time Frame: 5 years ]To compare the disease free survival of patients with Stage up to IA2 (T1aN0M0 or T1bN0M0) NSCLC managed either by SBRT or surgery.
- Overall Survival [ Time Frame: 5 years ]Overall survival rate at 5 years in both arms
- Level of morbidity [ Time Frame: 5 years ]Level of morbidity in both arms (CTCAE 4.0 - common toxicity criteria)
- Level of efficacy in the SBRT arm [ Time Frame: 5 years ]Level of efficacy in the SBRT arm (RECIST 1.1)
- QOL assessment [ Time Frame: 5 years ]QOL assessment with SF36 questionnaire (pre and post treatment) in both arms
- FEV1 and DLCO decline at 1-year post-treatment in both arms [ Time Frame: 1 year ]FEV1 or DLCO decline at 1-year post-treatment in both arms
- Health economic evaluation in both arms [ Time Frame: 5 years ]Health economic evaluation in both arms
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): NCT03431415
|Hôtel-Dieu de Québec (CHUQ)|
|Québec, Quebec, Canada, G1R2J6|
|Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval|
|Québec, Quebec, Canada, G1V4G5|
|Principal Investigator:||Paula A Ugalde Figueroa, MD||Associate Professor, Thoracic Surgeon, Research Coordinator|