Lung Cancer
Conditions
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 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.
Interventions
Treatments shall not be delivered more frequently than every other day.
Sponsors
Indiana University School of Medicine
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Any location eligible for SBRT (including, but not limited to, peripheral, chest wall abutting and central tumors) 7. N0 M0 disease 8. Plan to undergo four or five fraction SABR 9. 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
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. 4. KPS\<40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1 | 30 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Local control during Phase 2 | 2 years | 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). |
| Overall survival | 2 years | Length of time start of treatment that patients are still alive |
Countries
United States
Outcome results
None listed