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After completion of Phase I, it was decided not to initiate Phase II of the study.
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1/Dose Level 1 | Experimental | 11 Gy will be given in 5 fractions for a total dose of 55 Gy |
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| Phase 1/Dose Level 2 | Experimental | 12 Gy will be given in 5 fractions for a total dose of 60 Gy |
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| Phase 1/Dose Level 3 | Experimental | 13 Gy will be given in 5 fractions for a total dose of 65 Gy |
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| Phase 1/Dose Level 4 | Experimental | 14 Gy will be given in 5 fractions for a total dose of 70 Gy |
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| Phase 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Ablative Body Radiation (SABR) | Radiation | Treatments shall not be delivered more frequently than every other day. |
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| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tim Lautenschlaeger, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Health Methodist Hospital |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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| Overall survival |
Length of time start of treatment that patients are still alive |
| 2 years |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |