An interventional study of Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray) and Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray) in Lung Cancer and Lung Tumor, sponsored by Baptist Health South Florida. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Baptist Health South Florida · Not applicable, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
Browse Lung Neoplasms studies →Baptist Health South Florida is the lead sponsor of 52 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
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Exclusion Criteria:
Gross tumor volume (GTV) less than or equal to 1 cm from a lobar bronchus
Radiation: Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)
Gross tumor volume (GTV) less than or equal to 1 cm from the mainstem bronchus, trachea, or esophagus
Radiation: Stereotactic Adaptive Ablative Radiotherapy at 60 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.
Cohort B will include 30 patients with ultra-central tumors; the dose regimen prescribed is 60 Gy (Gray) in 8 fractions on consecutive days.
Treatment completion
Number of patients who completed treatment within +/- 5 days of intended treatment.
Time frame: 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.
Time frame: 12-month of treatment
Primary Tumor Control Rate
Primary tumor control rate at the maximum tolerated dose (MTD) based on each treatment cohort.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 3 and 12-month follow-up
Late-Toxicity
Rate of late (\>1 year) ≥ grade 3 adverse events related to treatment
Time frame: 1 year of treatment
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Baptist Health South Florida