Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2020-07-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type RADIATION

Treatments shall not be delivered more frequently than every other day.

Interventions

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Stereotactic Ablative Body Radiation (SABR)

Treatments shall not be delivered more frequently than every other day.

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No