Lung CancerLUNG STAARNCT04917224
Study of LUNG Stereotactic Adaptive Ablative Radiotherapy
A study testing Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray) and Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray) in people with Lung Cancer and Lung Tumor, run by Baptist Health South Florida.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Lung Tumor
- What is being tested?
- Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray) and Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2022to 1 Oct 2032
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years of age
- Clinical diagnosis of NSCLC
- Stage T1-2b (≤ 5 cm)
Who cannot join
- 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
About this study
Official title: Phase II Study of LUNG Stereotactic Adaptive Ablative Radiotherapy for Central and Ultracentral Tumors
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.
- Conditions
- Lung Cancer, Lung Tumor
- Being tested
- Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray), Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)Radiation
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.
Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)Radiation
Cohort B will include 30 patients with ultra-central tumors; the dose regimen prescribed is 60 Gy (Gray) in 8 fractions on consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Central lung tumors | Experimental | Gross tumor volume (GTV) less than or equal to 1 cm from a lobar bronchus Receives: Radiation: Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray) |
| Cohort B: Ultra-central lung tumors | Experimental | Gross tumor volume (GTV) less than or equal to 1 cm from the mainstem bronchus, trachea, or esophagus Receives: Radiation: Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment completion
Number of patients who completed treatment within +/- 5 days of intended treatment.
Measured: Plus or minus 5 days of 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.
Measured: 12-month of treatment
Secondary outcomes (6)
Primary Tumor Control Rate
Primary tumor control rate at the maximum tolerated dose (MTD) based on each treatment cohort.
Measured: 1 year of treatment
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.
Measured: 1 year of treatment
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.
Measured: 1 year of treatment
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.
Measured: Baseline
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).
Measured: 3 and 12-month follow-up
Late-Toxicity
Rate of late (>1 year) ≥ grade 3 adverse events related to treatment
Measured: 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start2 May 2022
- Primary completion1 Oct 2031 (estimated)
- Study completion1 Oct 2032 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rupesh Kotecha, MD, Principal investigator, Miami Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917224
- Sponsor's protocol ID
- 2020-KOT-005
- Acronym
- LUNG STAAR
- Status last verified
- Sep 2023
- First submitted
- 11 May 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34561039
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of LUNG Stereotactic Adaptive Ablative Radiotherapy for Central and Ultracentral Tumors
- ClinicalTrials.gov ID
- NCT04917224
- Acronym / sponsor ID
- LUNG STAAR / 2020-KOT-005
- Conditions
- Lung Cancer, Lung Tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 1 Oct 2031 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Central lung tumors | Experimental | Radiation: Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)Gross tumor volume (GTV) less than or equal to 1 cm from a lobar bronchus |
| Cohort B: Ultra-central lung tumors | Experimental | Radiation: Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)Gross tumor volume (GTV) less than or equal to 1 cm from the mainstem bronchus, trachea, or esophagus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years of age
- Clinical diagnosis of NSCLC
- Stage T1-2b (≤ 5 cm)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)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. | Radiation | Cohort A: Central lung tumors |
| Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)Cohort B will include 30 patients with ultra-central tumors; the dose regimen prescribed is 60 Gy (Gray) in 8 fractions on consecutive days. | Radiation | Cohort B: Ultra-central lung tumors |
Primary outcome
Treatment completion
Time frame: Plus or minus 5 days of treatment
Number of patients who completed treatment within +/- 5 days of intended treatment.
Number of patients experiencing adverse events
Time frame: 12-month of treatment
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.
6 secondary outcomes
Primary Tumor Control Rate
Time frame: 1 year of treatment
Progression-free survival (PFS)
Time frame: 1 year of treatment
Overall survival (OS)
Time frame: 1 year of treatment
Functional Assessment of Cancer Therapy - Lung (FACT-L)
Time frame: Baseline
EQ-5D-5L
Time frame: 3 and 12-month follow-up
Late-Toxicity
Time frame: 1 year of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 34561039Rosenberg 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupesh Kotecha, MD principal investigator
Miami Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray) and Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray) in people with Lung Cancer and Lung Tumor, run by Baptist Health South Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment completion (time frame: Plus or minus 5 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.