Study of LUNG Stereotactic Adaptive Ablative Radiotherapy (LUNG STAAR)

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Cancer; Lung Tumor
• Intervention / Treatment: Radiation: Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray); Radiation: Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Recruiting
      • Miami Cancer Institute
      • Contact: Rupesh C Kotecha, MD; Phone Number: 786-596-2000; Email: rupeshk@baptisthealth.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Central lung tumors; Gross tumor volume (GTV) less than or equal to 1 cm from a lobar bronchus	Radiation: 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.
Experimental: Cohort B: Ultra-central lung tumors; 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 B will include 30 patients with ultra-central tumors; the dose regimen prescribed is 60 Gy (Gray) in 8 fractions on consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Baptist Health South Florida
• Investigators: Principal Investigator: Rupesh Kotecha, MD, Miami Cancer Institute

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2032

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2020-KOT-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No