Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell-Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Center for Epidemiological Studies Depression Scale | Behavioral | — | UNRESOLVED |
| EQ-5D | Behavioral | — | UNRESOLVED |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 | Behavioral | — | UNRESOLVED |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 | Behavioral | — | UNRESOLVED |
| Medical Outcomes Study Social Support Survey | Behavioral | — | UNRESOLVED |
| Modified Medical Research Council | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-risk NSCLC participants
- description
- * 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
- interventionNames
- Behavioral: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30
- Behavioral: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13
- Behavioral: Modified Medical Research Council
- Behavioral: EQ-5D
- Behavioral: Center for Epidemiological Studies Depression Scale
- Behavioral: Medical Outcomes Study Social Support Survey
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available