Description:
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.
Title
- Brief Title: Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
- Official Title: Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
Clinical Trial IDs
- ORG STUDY ID:
IUSCC-0624
- NCT ID:
NCT03321747
Conditions
Purpose
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.
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 - 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.
Trial Arms
Name | Type | Description | Interventions |
---|
Phase 1/Dose Level 1 | Experimental | 11 Gy will be given in 5 fractions for a total dose of 55 Gy | |
Phase 1/Dose Level 2 | Experimental | 12 Gy will be given in 5 fractions for a total dose of 60 Gy | |
Phase 1/Dose Level 3 | Experimental | 13 Gy will be given in 5 fractions for a total dose of 65 Gy | |
Phase 1/Dose Level 4 | Experimental | 14 Gy will be given in 5 fractions for a total dose of 70 Gy | |
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. | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1 |
Time Frame: | 30 days |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Local control during Phase 2 |
Time Frame: | 2 years |
Safety Issue: | |
Description: | 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). |
Measure: | Overall survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Length of time start of treatment that patients are still alive |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Indiana University |
Last Updated
March 12, 2021