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Study of LUNG Stereotactic Adaptive Ablative Radiotherapy (LUNG STAAR)

Primary Purpose

Lung Cancer, Lung Tumor

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)
Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Clinical diagnosis of NSCLC
  • Stage T1-2b (≤ 5 cm)

Exclusion Criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (i.e., carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 1 year is permitted;
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Prior chemotherapy for the study cancer
  • Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression
  • Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Cohort A: Central lung tumors

    Cohort B: Ultra-central lung tumors

    Arm Description

    Gross tumor volume (GTV) less than or equal to 1 cm from a lobar bronchus

    Gross tumor volume (GTV) less than or equal to 1 cm from the mainstem bronchus, trachea, or esophagus

    Outcomes

    Primary Outcome Measures

    Treatment completion
    Number of patients who completed treatment within +/- 5 days of intended treatment.
    Number of patients experiencing adverse events
    No greater than 15 percent of patients experience a 12-month ≥ grade 3 toxicity and ≤1 grade 5 toxicity possibly, probably, or definitely related to treatment.

    Secondary Outcome Measures

    Primary Tumor Control Rate
    Primary tumor control rate at the maximum tolerated dose (MTD) based on each treatment cohort.
    Progression-free survival (PFS)
    Progression-free survival (PFS) is defined as the first occurrence of local and/or regional disease progression, distant metastases, second primary tumor, or death due to any cause. PFS time is measured from the date of start of SBRT to the date of the failure event for PFS.
    Overall survival (OS)
    Overall survival (OS) time is measured from the date of start of SBRT to the date of death due to any cause.
    Functional Assessment of Cancer Therapy - Lung (FACT-L)
    The Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life instrument has been extensively used for measuring quality of life in patients with lung cancer. There are 5 sections dealing with physical, family, emotional, functional well-being, and additional concerns. There are nine questions that are specific to lung cancer (LSC), including shortness of breath, cough, etc. The TOI (Trial Outcome Index) is the sum of the scores on the LCS and the physical well-being and functional well-being subscales of the FACT-L scale.
    EQ-5D-5L
    The five-item index score from EQ-5D-5L will be used to generate utility scores that will lie between 0 (Worst health state) and 1 (Best health state).
    Late-Toxicity
    Rate of late (>1 year) ≥ grade 3 adverse events related to treatment

    Full Information

    First Posted
    May 11, 2021
    Last Updated
    September 25, 2023
    Sponsor
    Baptist Health South Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04917224
    Brief Title
    Study of LUNG Stereotactic Adaptive Ablative Radiotherapy
    Acronym
    LUNG STAAR
    Official Title
    Phase II Study of LUNG Stereotactic Adaptive Ablative Radiotherapy for Central and Ultracentral Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    ViewRay (funding agency) has filed under Chapter 11, U.S. Bankruptcy Code. ViewRay's clinical research support is paused and studies will not be paid directly by ViewRay. As such, the sponsor has closed the study without enrolling participants.
    Study Start Date
    May 2, 2022 (Actual)
    Primary Completion Date
    October 1, 2031 (Anticipated)
    Study Completion Date
    October 1, 2032 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Baptist Health South Florida

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The proposed study expands on the principles of SBRT (Stereotactic Body Radiation Therapy) and SABR (Stereotactic Ablative Radiotherapy) for centrally located NSCLC (Non-Small Cell Lung Cancer) to further optimize outcomes in this patient population with utilization of the adaptive workflow to maintain tumor control rates but decrease the incidence and grade of treatment-related toxicities.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer, Lung Tumor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort A: Central lung tumors
    Arm Type
    Experimental
    Arm Description
    Gross tumor volume (GTV) less than or equal to 1 cm from a lobar bronchus
    Arm Title
    Cohort B: Ultra-central lung tumors
    Arm Type
    Experimental
    Arm Description
    Gross tumor volume (GTV) less than or equal to 1 cm from the mainstem bronchus, trachea, or esophagus
    Intervention Type
    Radiation
    Intervention Name(s)
    Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)
    Intervention Description
    Cohort A will include 30 patients with central tumors; the dose regimen prescribed is 50 Gy (Gray) in 5 fractions with a 40 hour inter-fraction interval.
    Intervention Type
    Radiation
    Intervention Name(s)
    Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)
    Intervention Description
    Cohort B will include 30 patients with ultra-central tumors; the dose regimen prescribed is 60 Gy (Gray) in 8 fractions on consecutive days.
    Primary Outcome Measure Information:
    Title
    Treatment completion
    Description
    Number of patients who completed treatment within +/- 5 days of intended treatment.
    Time Frame
    Plus or minus 5 days of treatment
    Title
    Number of patients experiencing adverse events
    Description
    No greater than 15 percent of patients experience a 12-month ≥ grade 3 toxicity and ≤1 grade 5 toxicity possibly, probably, or definitely related to treatment.
    Time Frame
    12-month of treatment
    Secondary Outcome Measure Information:
    Title
    Primary Tumor Control Rate
    Description
    Primary tumor control rate at the maximum tolerated dose (MTD) based on each treatment cohort.
    Time Frame
    1 year of treatment
    Title
    Progression-free survival (PFS)
    Description
    Progression-free survival (PFS) is defined as the first occurrence of local and/or regional disease progression, distant metastases, second primary tumor, or death due to any cause. PFS time is measured from the date of start of SBRT to the date of the failure event for PFS.
    Time Frame
    1 year of treatment
    Title
    Overall survival (OS)
    Description
    Overall survival (OS) time is measured from the date of start of SBRT to the date of death due to any cause.
    Time Frame
    1 year of treatment
    Title
    Functional Assessment of Cancer Therapy - Lung (FACT-L)
    Description
    The Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life instrument has been extensively used for measuring quality of life in patients with lung cancer. There are 5 sections dealing with physical, family, emotional, functional well-being, and additional concerns. There are nine questions that are specific to lung cancer (LSC), including shortness of breath, cough, etc. The TOI (Trial Outcome Index) is the sum of the scores on the LCS and the physical well-being and functional well-being subscales of the FACT-L scale.
    Time Frame
    Baseline
    Title
    EQ-5D-5L
    Description
    The five-item index score from EQ-5D-5L will be used to generate utility scores that will lie between 0 (Worst health state) and 1 (Best health state).
    Time Frame
    3 and 12-month follow-up
    Title
    Late-Toxicity
    Description
    Rate of late (>1 year) ≥ grade 3 adverse events related to treatment
    Time Frame
    1 year of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years of age Clinical diagnosis of NSCLC Stage T1-2b (≤ 5 cm) Exclusion Criteria: Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (i.e., carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 1 year is permitted; Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields Prior chemotherapy for the study cancer Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rupesh Kotecha, MD
    Organizational Affiliation
    Miami Cancer Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34561039
    Citation
    Rosenberg SA, Mak R, Kotecha R, Loo BW Jr, Senan S. The Nordic-HILUS Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window. J Thorac Oncol. 2021 Oct;16(10):e79-e80. doi: 10.1016/j.jtho.2021.06.030. No abstract available.
    Results Reference
    derived
    Links:
    URL
    https://baptisthealth.net/en
    Description
    Related Info

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