TerminatedPhase 1NCT03321747

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

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.

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

StatusTerminated
PhasePhase 1
U.S. locations3
SponsorIndiana University
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.

03
Public criteria

Who may be able to participate

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

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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