Status:
TERMINATED
Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Indiana University School of Medicine
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
1. 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 - Determin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03321747
Start Date
October 20 2017
End Date
July 9 2020
Last Update
July 26 2022
Active Locations (3)
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1
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
2
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
3
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202