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

Phase 1

Terminated

• Conditions: Lung Cancer
• Interventions: Radiation: Stereotactic Ablative Body Radiation (SABR)

• Registration Number: NCT03321747
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-10-20
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-26
• Primary Completion: 2020-07-09
• Study Completion: 2020-07-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1/Dose Level 1	Stereotactic Ablative Body Radiation (SABR)	11 Gy will be given in 5 fractions for a total dose of 55 Gy
Phase 1/Dose Level 3	Stereotactic Ablative Body Radiation (SABR)	13 Gy will be given in 5 fractions for a total dose of 65 Gy
Phase 1/Dose Level 2	Stereotactic Ablative Body Radiation (SABR)	12 Gy will be given in 5 fractions for a total dose of 60 Gy
Phase 2	Stereotactic Ablative Body Radiation (SABR)	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.
Phase 1/Dose Level 4	Stereotactic Ablative Body Radiation (SABR)	14 Gy will be given in 5 fractions for a total dose of 70 Gy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Health Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States