Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie. weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side effects.

Official Title
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Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Adaptive radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Willing to provide informed consent ECOG performance status 0-2 Histologically confirmed non-small cell lung carcinoma Locally advanced stage IIIA or IIIB lung carcinoma according to AJCC 7th edition Expected lung V20 of 35-60%, as determined at the time of 4D-CT simulation Assessment by medical oncologist and radiation oncologist, with adequate hepatic and renal function for administration of cisplatin-based doublet chemotherapy, at the discretion of the medical oncologist Exclusion Criteria: Serious medical comorbidities or other contraindications to radiotherapy or chemotherapy Prior history of lung cancer within 5 years Prior thoracic radiation at any time Metastatic disease in some select cases, patients with a solitary metastasis (i.e. brain metastasis) may receive radical chemoradiotherapy after resection/ablation of their metastatic lesion, as standard practice. In such cases, the patient may be enrolled onto this study at the discretion of the local principle investigator once the metastasis has been treated. inability to attend full course of radiotherapy of follow-up visits 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: Shrinking Target Adaptive Radiotherapy<br>Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer | Radiation: Adaptive radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor reduction |  | 2.5 years (end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of tumor shrinkage |  | 2.5 years (end of treatment) | 
| Change in lung dose |  | 2.5 years (end of treatment) | 
| Delivered doses |  | 2.5 years (end of treatment) | 
| Radiation pneumonitis rates |  | 6 months, 12 months, 18 months, 24 months, 30 months (semi-annually) | 
| Local control |  | 2.5 years (end of treatment) | 
| Overall survival |  | 2.5 years |