SBRT (Stereotactic Body Radiation Therapy) vs. Surgery in High Risk Patients With Early Stage Lung Cancer

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.

Conditions

• Carcinoma, Non-Small-Cell-Lung
• Non-Small Cell Lung Cancer
• Nonsmall Cell Lung Cancer

Interventions

BEHAVIORAL

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30

* 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

BEHAVIORAL

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13

* 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

BEHAVIORAL

Modified Medical Research Council

* 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

BEHAVIORAL

EQ-5D

* 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

BEHAVIORAL

Center for Epidemiological Studies Depression Scale

* 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

BEHAVIORAL

Medical Outcomes Study Social Support Survey

* 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

Sponsors & Collaborators

• Varian Medical Systems

  collaborator INDUSTRY

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Cliff Robinson, M.D. · Washington University School of Medicine

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-11

Primary Completion

2020-11-01

Completion

2020-11-01

Countries

• United States

Study Locations