SBRT (Stereotactic Body Radiation Therapy) vs. Surgery in High Risk Patients With Early Stage Lung Cancer
Objective Treatment Allocation With SBRT vs. Surgery in High Risk Patients With Early Stage Lung Cancer Within an Accountable Care Collaborative Effort Between Surgery and Radiation Oncology
1 other identifier
interventional
217
1 country
1
Brief Summary
A principle objective of the study is to create a validated risk model for treatment selection. This will greatly enhance the ability to counsel patients regarding their specific risks/benefit ratio for surgery or SBRT. This will improve informed decision making on the part of the patient, and remove much of the subjectivity of treatment selection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 11, 2015
CompletedFirst Submitted
Initial submission to the registry
September 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedApril 8, 2021
April 1, 2021
5.1 years
September 17, 2015
April 6, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Treatment selection model for high-risk early stage NSCLC patient population using comorbidity
* Comorbidity scoring will be performed by interview and chart review including the Adult Comorbidity Evaluation 27 (ACE-27), Charlson Comorbidity Index (CCI), Global Initiative for Chronic Obstructive Lung Disease (GOLD), Cumulative Illness Rating Scale (CIRS), and COMorbidities in Chronic Obstructive Lung Disease (COMCOLD) * All of the comorbidity indices grade comorbidities from mild to severe. The investigators will use the data obtained from cumulative collected indices to determine the severity of patient comorbidities. * The data obtained from this group of patients will be compared with the previously obtained data from patients who had surgery for their stage I NSCLC.
Up to 90 days post treatment
Treatment selection model for high-risk early stage NSCLC patient population using risk indices
* For determination of frailty, Fried's frailty criteria, a validated measurement tool which includes assessment of weight loss, exhaustion, activity level, grip strength, and walk speed. Fraility is classified using a validated score of 0-5 with patients scoring 4-5 considered frail, 2-3 considered intermediately frail, and 0-1 nonfrail. * Activities of daily living (Katz Activities of Daily Living) and instrumental activities of daily living (IADL) will be assessed. Both the ADL and IADL look at independence. The ADL has 6 questions/the IADL has 8 questions and the patient will receive a point for each question if he or she is considered independent. A score of 0 means the person if very dependent and very frail. A score of 6 (ADL) or 8 (IADL) means a person if very independent and not frail. * The data obtained from this group of patients will be compared with the previously obtained data from patients who had surgery for their stage I NSCLC.
Up to 90 days post treatment
Treatment selection model for high-risk early stage NSCLC patient population using HRQOL (health related quality of life) endpoints
* HRQOL will be measured by the European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ) C30, EORTC QLQ-LC13, Modified Medical Research Council (mMRC), EQ-5D, CES-D, and Medical Outcomes Study Social Support Survey (MOS-SSS). * Utility assessments will also be used and will serve as a quantitative measure of patient preferences and will be utilized to estimate quality adjusted life years (QALYs) to better incorporate quantity of survival, as well as quality of life consequences of stage I lung cancer interventions.
Up to 24 months post treatment
Secondary Outcomes (8)
Potential savings in cost using the model in this study
Up to 90 days
Comprehensive collaborative REDCap database to support the retrospective and prospective data collection
Up to 5 years post treatment
Costs of surgery
Up to 90 days
Costs of SBRT
Up to 90 days
Potential cost savings with implementation of a novel ACO for stage I NSCLC
Up to 90 days
- +3 more secondary outcomes
Study Arms (1)
High-risk NSCLC participants
EXPERIMENTAL* Baseline assessment of demographics and comorbidities * Comorbidity scoring by interview and chart review: the Adult Comorbidity Evaluation 27, Charlson Comorbidity Index, Global Initiative for Chronic Obstructive Lung Disease, Cumulative Illness Rating Scale, and COMorbidities in Chronic Obstructive Lung Disease. * Katz Activities of Daily Living: assessment of grip strength, walk speed, and activities of daily living * HRQOL questionnaires will also be administered prior to treatment and then repeated throughout follow-up: the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30, EORTC QLQ-LC13, Modified Medical Research Council, EQ-5D, CES-D, and Medical Outcomes Study Social Support Survey. * All questionnaire responses will be obtained with the use of a computer assisted interview system which can be used to collect data in person or through telephone interviews
Interventions
* 30 quality of life questions for the participant to answer * The first 28 questions have answers that range from 1 (Not at All) to 4 (Very Much) * The final 2 questions answers range from 1 (Very Poor) to 7 (Excellent) * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
* 13 quality of life questions for the participant to answer * The answers range from 1 (Not at All) to 4 (Very Much) * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
* Participants is given 5 grades to choose from ranging from 0 to 4 and participant will choose grade * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
* 5 headings with 5 statements and the participant will check the box that best describes how he or she feels that day * The second part shows a scale ranging from 0 (worst health) to 100 (best health) and the participant chooses the best number on the scale * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
* 20 quality of life questions for the participant to answer * Answers range from "Rarely or none of the time" to "Most or all of the time" * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
* 19 quality of life questions for the participant to answer * Answers from from 1 (None of the time) to 5 (All of the time) * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
Eligibility Criteria
You may qualify if:
- Newly diagnosed suspected or proven clinical stage I NSCLC (T1 or T2, N0, M0) with no prior treatment for this disease.
- At least 18 years of age.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Varian Medical Systemscollaborator
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cliff Robinson, M.D.
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2015
First Posted
September 29, 2015
Study Start
September 11, 2015
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
April 8, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share