Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung

Study Overview
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Brief Summary
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The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (SABR) is safe and improves local control for early state squamous cell carcinoma of the lung. While three fraction SABR is effective for the treatment of early stage non small cell lung carcinoma (NSCLC) of all histologies, it is not safe for many patients. While four and five fraction SABR is safe, recently published data and our institutional data suggests that local control for early stage squamous cell carcinoma of the lung using the current four or five fraction SABR is suboptimal.

Detailed Description
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Primary Objectives During Phase I study - Determine the safety and maximum tolerated radiation dose for five fraction SABR for squamous cell cancer of the lung. During Phase II study - Determine 2 year local control of dose escalated five fraction SABR vs. institutional historical control standard dose SABR in squamous cell cancer of the lung. Phase II Secondary Objectives Determine overall survival, progression free survival and patterns of failure after SABR. Determine tolerability of dose escalated SABR.

Official Title
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Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: Stereotactic Ablative Body Radiation (SABR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age ≥ 18 at time of consent. Ability to provide written informed consent and HIPAA authorization. Pathological diagnosis of squamous cell carcinoma of the lung. Staging PET/CT (invasive mediastinal staging strongly encouraged but not required). Tumors < 7cm Any location eligible for SBRT (including, but not limited to, peripheral, chest wall abutting and central tumors) N0 M0 disease Plan to undergo four or five fraction SABR Baseline PFTs available within 6 months of treatment start or will be obtained prior to treatment start (no finding will exclude patient from enrollment in trial) Exclusion Criteria Previous radiation therapy to the lung per investigator discretion. Inability to comply with treatment per investigator discretion. Inability to follow standard of care follow up recommendations per investigator discretion. KPS<40

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: Sequential Assignment
Interventional Model Description: This trial is a Phase I/II study designed to determine the maximum tolerated radiation dose and evaluate the efficacy of dose escalated SABR for early stage lung squamous cell carcinoma. *The Phase l portion of this study was completed. However; the trial will not continue into Phase II as originally planned.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1/Dose Level 1<br>11 Gy will be given in 5 fractions for a total dose of 55 Gy | Radiation: Stereotactic Ablative Body Radiation (SABR)<br>* Treatments shall not be delivered more frequently than every other day.<br>|
| Experimental: Phase 1/Dose Level 2<br>12 Gy will be given in 5 fractions for a total dose of 60 Gy | Radiation: Stereotactic Ablative Body Radiation (SABR)<br>* Treatments shall not be delivered more frequently than every other day.<br>|
| Experimental: Phase 1/Dose Level 3<br>13 Gy will be given in 5 fractions for a total dose of 65 Gy | Radiation: Stereotactic Ablative Body Radiation (SABR)<br>* Treatments shall not be delivered more frequently than every other day.<br>|
| Experimental: Phase 1/Dose Level 4<br>14 Gy will be given in 5 fractions for a total dose of 70 Gy | Radiation: Stereotactic Ablative Body Radiation (SABR)<br>* Treatments shall not be delivered more frequently than every other day.<br>|
| Experimental: Phase 2<br>The maximum tolerated radiation dose determined during Phase 1 (i.e. 11, 12, 13, or 14 Gy) will be given in 5 fractions for a total dose of 55, 60, 65, or 70 Gy. | Radiation: Stereotactic Ablative Body Radiation (SABR)<br>* Treatments shall not be delivered more frequently than every other day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1 | Any event per CTCAE v.4 that occurs within 30 days from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control during Phase 2 | Failures will be classified as local failures if failing within or immediately adjacent to the PTV, unless judged by the investigator team to convincingly be a separate lesion from the treated lesion (i.e. new lesion within a planning target volume but across a fissure). | 2 years | 
| Overall survival | Length of time start of treatment that patients are still alive | 2 years |