Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/21/2018 |
| Start Date: | October 20, 2017 |
| End Date: | June 30, 2022 |
| Contact: | Kathy Lauer |
| Email: | klauer@iuhealth.org |
| Phone: | 317-962-3172 |
Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
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.
(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.
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 - 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.
2. Phase II Secondary Objectives
- Determine overall survival, progression free survival and patterns of failure after
SABR.
- Determine tolerability of dose escalated SABR.
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.
2. Phase II Secondary Objectives
- Determine overall survival, progression free survival and patterns of failure after
SABR.
- Determine tolerability of dose escalated SABR.
Inclusion Criteria
1. Age ≥ 18 at time of consent.
2. Ability to provide written informed consent and HIPAA authorization.
3. Pathological diagnosis of squamous cell carcinoma of the lung.
4. Staging PET/CT (invasive mediastinal staging strongly encouraged but not required).
5. Tumors < 7cm
6. N0 M0 disease
7. Baseline PFTs available or will be obtained prior to treatment start
Exclusion Criteria
1. Previous radiation therapy to the lung per investigator discretion.
2. Inability to comply with treatment per investigator discretion.
3. Inability to follow standard of care follow up recommendations per investigator
discretion.
We found this trial at
3
sites
Indianapolis, Indiana 46202
Principal Investigator: Tim Lautenschlaeger, MD
Phone: 317-962-3172
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Indianapolis, Indiana 46202
Principal Investigator: Tim Lautenschlaeger, MD
Phone: 317-962-3172
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535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
Principal Investigator: Tim Lautenschlaeger, MD
Phone: 317-962-3172
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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