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Withdrawn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
About this trial
This is an interventional treatment trial for Lung Cancer
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
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
NCT ID
NCT04917224
First Posted
May 11, 2021
Last Updated
September 25, 2023
Sponsor
Baptist Health South Florida
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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Study of LUNG Stereotactic Adaptive Ablative Radiotherapy
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