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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Central lung tumors | Experimental | Gross tumor volume (GTV) less than or equal to 1 cm from a lobar bronchus |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment completion | Number of patients who completed treatment within +/- 5 days of intended treatment. | 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. | 12-month of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Tumor Control Rate | Primary tumor control rate at the maximum tolerated dose (MTD) based on each treatment cohort. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rupesh Kotecha, MD | Miami Cancer Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34561039 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. |
|
| 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. | 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. | 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). | 3 and 12-month follow-up |
| Late-Toxicity | Rate of late (>1 year) ≥ grade 3 adverse events related to treatment | 1 year of treatment |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |