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TerminatedPhase 1NCT03321747
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Ablative Body Radiation (SABR)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 26, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Indiana University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Indiana University
Interventions being studied
Radiation: Stereotactic Ablative Body Radiation (SABR)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Indiana University Health HospitalIndianapolis, Indiana
  • Indiana University Health Methodist HospitalIndianapolis, Indiana
  • Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 26, 2022. Always confirm current availability with the study team.

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