Lung Cancer, Lung Tumor
Conditions
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.
Interventions
RADIATIONStereotactic 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.
RADIATIONStereotactic 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.
Sponsors
Baptist Health South Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment completion | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 1 year of treatment | 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) | Baseline | 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. |
| Primary Tumor Control Rate | 1 year of treatment | Primary tumor control rate at the maximum tolerated dose (MTD) based on each treatment cohort. |
| Late-Toxicity | 1 year of treatment | Rate of late (\>1 year) ≥ grade 3 adverse events related to treatment |
| EQ-5D-5L | 3 and 12-month follow-up | 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). |
| Progression-free survival (PFS) | 1 year of treatment | 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. |
Outcome results
None listed