Clinical Trials /

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

NCT03321747

Description:

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.

Related Conditions:
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
  • Official Title: Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0624
  • NCT ID: NCT03321747

Conditions

  • Lung Cancer

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Phase 1/Dose Level 1Experimental11 Gy will be given in 5 fractions for a total dose of 55 Gy
    Phase 1/Dose Level 2Experimental12 Gy will be given in 5 fractions for a total dose of 60 Gy
      Phase 1/Dose Level 3Experimental13 Gy will be given in 5 fractions for a total dose of 65 Gy
        Phase 1/Dose Level 4Experimental14 Gy will be given in 5 fractions for a total dose of 70 Gy
          Phase 2ExperimentalThe 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.

            Eligibility Criteria

                    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. N0 M0 disease
            
                      7. Baseline PFTs available or will be obtained prior to treatment start
            
                    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.
                  
            Maximum Eligible Age:N/A
            Minimum Eligible Age:18 Years
            Eligible Gender:All
            Healthy Volunteers:No

            Primary Outcome Measures

            Measure:Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1
            Time Frame:30 days
            Safety Issue:
            Description: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

            Measure:Local control during Phase 2
            Time Frame:2 years
            Safety Issue:
            Description: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).
            Measure:Overall survival
            Time Frame:2 years
            Safety Issue:
            Description:Length of time start of treatment that patients are still alive

            Details

            Phase:Phase 1/Phase 2
            Primary Purpose:Interventional
            Overall Status:Recruiting
            Lead Sponsor:Indiana University

            Last Updated