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

NCT ID: NCT02562027

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-11
• Study Completion Date: 2020-11-01

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.

Detailed Description

The development of SBRT for treatment of stage I NSCLC (non-small cell lung cancer) inspired the collaboration between thoracic surgery and radiation oncology and has prompted the investigators to work closely together to evaluate the relative role of SBRT and surgery. Comparative studies of these modalities have been limited in number and are often difficult to interpret due to variability in methodological issues. The productive collaboration has resulted in publication of several studies comparing SBRT and surgery utilizing propensity score based analyses to match patients from each group. However, matching on limited numbers of variables between patients ultimately selected for therapy based largely on their real or perceived comorbidity leads to significant reporting bias, and therefore methods to comprehensively assess comorbidity are necessary.

As extension of above, a very real ongoing challenge that the investigators have evaluated within clinical practice is that current guidelines defining the high risk patient are subjective and prone to physician bias. A recent secondary analysis of clinical trial inclusion criteria for SBRT underscored this bias by demonstrating that many patients that were considered inoperable were perhaps reasonable surgical candidates. Based on standard pulmonary function tests the inoperable SBRT patients had a diffusion capacity 33% higher than the high risk surgical patients in ACOSOG Z4032. Conversely, stratification of high risk surgical patients within ACOSOG Z4032 trial identified an extremely high risk subset (median DLCO% 30%, FEV1% 39%) with a 90-day 3+ adverse event rate of 48% compared to the lowest risk subset (DLCO% 69%, FEV1% 56%) with a 90-day 3+ adverse event rate of only 24%. In the absence of a clinical trial or a prospective database, there is currently no objective algorithm to guide the assignment of surgery versus SBRT.

Attempts to objectively stratify risk within the surgical population have been challenging. Risk models based on the European Thoracic Database and the Society of Thoracic Surgeons Database are not yet robust enough to guide decision-making regarding treatment assignment or classification of the very high risk surgical patient where alternative therapies may be preferable. Unfortunately, one of the current limitations to stratifying these high risk patients is that these patients are followed by physicians in independent specialties. The STS Thoracic Surgical Database does not include patients that undergo SBRT therefore it is difficult to create an inclusive algorithm for operable and inoperable patients. 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. Inclusion of unique metrics such as HRQOL data will further bolster the benefit to the patient by making it more patient-centric, rather than focusing on cancer outcomes alone.

As the implementation of the Affordable HealthCare Act (AHCA) continues, physicians will experience additional pressure to cut costs while maintaining or improving the quality of care provided. The current fee-for-service system is often criticized for being compartmentalized and fragmented without well-defined incentives for quality improvement.

Initiatives of the AHCA have included efforts to test care models to reduce hospital associated conditions, bundled payment plans for care improvement, and shared savings programs for accountable care organizations whereby participating providers who meet certain quality standards share in any savings achieved for the Medicare program. These are just some of the efforts designed to rein in the cost of medical care while improving the transparency and quality of care. Pilot efforts involving bundling of payments for coronary artery bypass grafting resulted in Medicare savings of $40 million with simultaneous reduced in-hospital mortality. These types of initiatives are likely to become more commonplace in the United States as efforts to create new models of care to constrain cost are introduced.

With the stimulus of these initiatives for novel systems of healthcare delivery the investigators recognized that a model of bundled payment for treatment of stage I NSCLC may not only reduce overall costs associated with treatment of stage I lung cancer but potentially improve the quality of care provided. At Washington University the investigators have taken a preemptive measure to create an accountable care organization (ACO) between the Department of Radiation Oncology and the Department of Thoracic Surgery with a focused approach on the treatment of stage I NSCLC. Important components of this collaborative effort include a bundled payment system for episodes of care involving the treatment selection, implementation, and follow up care of patients with stage I lung cancer as well as prospective assessment of quality of care measures.

The impetus for the development of this unique collaboration between radiation oncology and thoracic surgery stems from the ongoing interest in improving the quality of care for patients with early stage NSCLC. The clinical research focus has been on determining the best treatment strategies for the significant number of patients with stage I lung cancer considered medically inoperable or high risk surgical candidates. In the aging population, pulmonary insufficiency, cardiac disease, as well as other comorbidities may preclude surgery or place patients at significant risk for complications after surgery. The evolution of stereotactic body radiotherapy (SBRT) in the medically inoperable population has resulted in relatively low local recurrence rates ranging from 3-20% with favorable overall and disease-free survival in inoperable patients with Stage I NSCLC.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

• 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

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

Intervention Type: BEHAVIORAL

• 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

Modified Medical Research Council

Intervention Type: BEHAVIORAL

• 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

EQ-5D

Intervention Type: BEHAVIORAL

• 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

Center for Epidemiological Studies Depression Scale

Intervention Type: BEHAVIORAL

• 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

Medical Outcomes Study Social Support Survey

Intervention Type: BEHAVIORAL

• 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

EORTC QLQ-C30; EORTC QLQ-LC13; mMRC; -Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment; CES-D; MOS-SSS

Eligibility Criteria

Inclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cliff Robinson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201509035

Identifier Type: -

Identifier Source: org_study_id