Lung Cancer Clinical Trial
Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
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