A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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Stereotactic ablative radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. The study combines SABR and surgery to treat non-small cell lung cancer. SABR will be done first, with surgery done approximately 10 weeks later. There will be some extra imaging done before and after the SABR. The purpose of this study is to determine how effective SABR is in killing the cancer cells, and if SABR can help make surgery more effective.

Detailed Description
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The advent of stereotactic ablative radiotherapy (SABR) has provided a novel, promising treatment for patients with early-stage non-small cell lung cancer. SABR uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy. The use of SABR as neoadjuvant therapy prior to surgery may provide a novel therapeutic opportunity. In oncology, the use of neoadjuvant radiotherapy or chemoradiotherapy prior to surgery has become widespread for several types of cancer, and in many instances improves local control over and/or survival compared to surgery alone. Neoadjuvant radiotherapy provides several theoretical advantages, including potentially decreasing the rate of positive margins, decreasing the size of the required resection, or by sterilizing the tumor to avoid seeding of circulating tumor cells during surgery. Although radiologic outcomes after SABR illustrate local control rates of approximately 90% in many studies, the presence of residual post-treatment fibrosis may confound this assessment of recurrence. The goal of this study is to evaluate a novel treatment approach: the combination of neoadjuvant SABR followed by surgical resection in patients with T1T2N0 non-small cell lung cancer, in order to measure the true pathologic rates of local control after SABR, to develop new imaging biomarkers or response, and to assess clinical outcomes, including toxicity, relapse patterns, and survival.

Official Title
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A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy plus Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Willing to provide informed consent Histologically confirmed non-small cell lung cancer Tumor stage T1 or T2a (less than or equal to 5 cm) No evidence of nodal disease (N0) No evidence of distant metastases (M0) Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy > 6 months Adequate forced expiratory volume at one second (FEV1), defined as a predicted post-operative FEV1 of 30% or greater Exclusion Criteria: Serious medical comorbidities or other contraindications to radiotherapy or surgery Prior history of lung cancer within 5 years Prior thoracic radiation at any time Inability to attend full course of radiotherapy, surgery, or follow-up visits Contrast allergy Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic Body Radiation Therapy plus Surgery<br>Stereotactic body radiation therapy followed by surgical resection | Radiation: Stereotactic Body Radiation Therapy plus Surgery<br>* Stereotactic body radiation therapy followed by surgical resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Percentage of patients who exhibit a lack of viable tumor after surgical resection | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of imaging biomarkers | Predictive value of novel imaging biomarkers compared to pathologic outcome (complete response or non-complete response to treatment) | 2.5 years | 
| Tumor recurrence | Time to local recurrence, regional recurrence, and distant recurrence of disease will be measured | 7 years | 
| Toxicity of the combined approach of SABR + surgery | Toxicity of the combined approach of SABR plus surgical resection will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4. | 7 years | 
| Quality of life measures , including physical well-being, functional well-being, and lung-cancer subscale questions | The FACT-TOI is a summary score derived from the FACT-L and is composed of 21 items, including physical well-being, functional well-being, and lung-cancer subscale questions | 7 years |