Study Comparing Two Different Schedules of Radiation for Early-stage Lung Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03706027|
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : August 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Device: radiation therapy-3 fractions Device: Radiation therapy-5 fractions||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Three- Versus Five-Fraction Regimens of Stereotactic Body Radiotherapy for Peripheral Early-Stage Non-Small-Cell Lung Cancer: A Prospective Randomized Phase II Study|
|Actual Study Start Date :||December 15, 2018|
|Estimated Primary Completion Date :||November 15, 2025|
|Estimated Study Completion Date :||November 15, 2025|
|Active Comparator: Stereotactic body radiotherapy- 3 fractions||
Device: radiation therapy-3 fractions
Radiation therapy given in a 3 fraction schedule (over 3 days). Total dose is 54 Grays.
|Active Comparator: Stereotactic body radiotherapy- 5 fractions||
Device: Radiation therapy-5 fractions
Radiation therapy given in 5 fractions (over 5 days). Total dose is 60 Grays.
- frequency of grade 3 treatment related toxicities or higher [ Time Frame: 1 year ]Toxicities will be assessed using the National Cancer Institute common toxicities criteria version 4.0. The rates of grade 3 or higher adverse events at 1 year will be calculated as the proportion of patients who have any adverse event of interest by the end of year 1 among the total analyzable patients in each arm.
- mean survival time of patients with overall survival [ Time Frame: 3 years ]The failure event for overall survival is a death due to any cause. Survival time is measured from the date of randomization to the date of death or last follow up.
- proportion of patients with disease-free survival [ Time Frame: 3 years ]The failure event for disease-free survival is defined as death due to any cause, local failure, marginal failure, involved node failure, regional failure, distant metastasis, or second primary.
- proportions of patients with primary tumor control [ Time Frame: 3 years ]Marginal failures will be considered events for primary tumor failure. The primary tumor control rate at 1 year will be calculated as the number of patients who do not have a local progression event by the total number of analyzable patients in each arm at 1 year.
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): NCT03706027
|Contact: Deepinder Singh, MDemail@example.com|
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Deepinder Singh, MD 585-275-5623 firstname.lastname@example.org|