Study of LUNG Stereotactic Adaptive Ablative Radiotherapy

Not Applicable

Withdrawn

• Conditions: Lung Cancer; Lung Tumor
• Interventions: Radiation: Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray); Radiation: Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)

• Registration Number: NCT04917224
• Lead Sponsor: Baptist Health South Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-08
• Study Start: 2022-05-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26
• Primary Completion: 2031-10-01
• Study Completion: 2032-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A: Central lung tumors	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	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

Primary Outcome Measures

Name	Time	Method
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.
Treatment completion	Plus or minus 5 days of treatment	Number of patients who completed treatment within +/- 5 days of intended treatment.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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).
Primary Tumor Control Rate	1 year of treatment	Primary tumor control rate at the maximum tolerated dose (MTD) based on each treatment cohort.
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.
Late-Toxicity	1 year of treatment	Rate of late (\>1 year) ≥ grade 3 adverse events related to treatment