Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
Stopped early · Phase 1
Conditions studied: Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT03321747
- Run by
- Indiana University
- People needed
- 13
- Starts
- 2017-10-20
- Expected to finish
- 2020-07-09
- Last updated by the study team
- 2022-07-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Indiana University Health Hospital — Indianapolis, Indiana, United States
- Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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