Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to examine the use of hypofractionated accelerated radiation therapy (HART) to treat locally advanced lung cancer. Depending on the location and size of the tumor.

Official Title
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Phase I Trial of Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: Hypofractionated accelerated radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically documented malignancy of the lung including non-small cell lung cancer or small cell lung cancer planned for definitive therapy with fractionated radiation (60-66 Gy) and concurrent systemic therapy ECOG performance status of 0-2 Age > 18 years old Ability to understand and the willingness to personally sign the written IRB approved informed consent document Estimated life expectancy of 12 weeks or longer Exclusion Criteria: Contraindication to receiving radiotherapy or systemic therapy as determined by treating radiation and medical oncologist Age < 18 years old Tumor directly invading the major pulmonary arteries, aorta, heart or proximal bronchial tree Diagnosis of interstitial pulmonary fibrosis Previous radiation therapy to the thorax that would result in overlapping high dose radiation fields

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated accelerated radiation therapy (HART)<br>Patients will either be treated with 60-66 Gy in 30, 25, or 20 fractions based on ability to meet constraints to key organs at risk | Radiation: Hypofractionated accelerated radiation therapy<br>* Hypofractionated accelerated radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting pulmonary and esophageal toxicity | Toxicities will be scored by the CTCAE v5.0 criteria. Specific toxicities evaluated are grade 2+ pneumonitis and grade 3+ esophagitis as well as other G3+ pulmonary, esophageal or cardiac toxicities that could be probably or definitely attributed to rT. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and Late Toxicities | Patients will be evaluated by the rates of acute and late grade 2+ toxicities including lung, esophageal, cardiac, chest wall, and neurologic. | 36 months | 
| Integrated adaptive dosing regimen with an automated planning system | Evaluating the feasibility of integrating an adaptive dosing regimen with an automated planning system with the percentage of automated plans used and the time to plan approval. | 36 months | 
| Progression free survival | Determine progression free survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy | 36 months | 
| Overall survival | Determine overall survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy | 36 months | 
| Local control | Determine local control in patients treated with hypofractionated radiation therapy with concurrent systemic therapy | 36 months |