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
Status: Completed
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
United States
Missouri
Washington University School of Medicine
Saint Louis
Time Frame
Start Date: 2015-09-11
Completion Date: 2020-11-01
Participants
Target number of participants: 217
Treatments
Experimental: High-risk NSCLC participants
* 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
Authors
Cliff Robinson, Varun Puri, Bryan Meyers, Daniel Kreisel, Benjamin Kozower, Dennis Hallahan, Parag Parikh, A. Sasha Krupnick
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: Varian Medical Systems