Pilot Study of SGRT Alone vs. SGRT With Fiducials for Breath Hold SBRT tx of the Lung

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Device: SGRT

• Registration Number: NCT04060927
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This is a pilot study designed to to provide data and experience comparing two different techniques of breath hold SBRT treatments. The first technique will include SGRT, but with the assistance of implanted fiducials. Subjects will be treated with a breath hold technique utilizing SGRT, but will also be imaged during treatment with fiducial match. The second technique will utilize SGRT for breath hold treatments without the assistance of implanted fiducials/continuous imaging.

Detailed Description

The study's primary objective is estimate the incidence of SBRT and fiducial-related pulmonary toxicities for subjects treated with SBRT who have tumors that move ≥ 1 cm in 3 different cohorts: 1) free breathing with SGRT 2) breath hold utilizing SGRT only; 3) breath hold utilizing SGRT in combination with implanted fiducials. Secondary objectives also include Estimate reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials estimating local control for SBRT in subjects treated in the three different cohorts, estimating overall survival, and evaluating quality of life. A safety objective of estimating acute and long-term grade 2 or higher non-hematologic toxicities attributed to SBRT/fiducial implantation in subjects treated in the three different cohorts will also be explored.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Study Start: 2019-09-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	SGRT	Breath hold SBRT with SGRT in combination with implanted fiducials
Group 1	SGRT	Freebreathing SBRT with SGRT
Group 2	SGRT	Breath hold SBRT with SGRT

Primary Outcome Measures

Name	Time	Method
Incidence of SBRT and fiducial-related pulmonary toxicities as assessed by NCI CTCAE v.5.0	12 months	The outcome will be recorded as a binary variable determined for each subject indicating whether or not the subject had at least one grade 2 or higher pulmonary toxicity related to SBRT or implantation of fiducials.

Secondary Outcome Measures

Name	Time	Method
Local control of treated tumor(s)	up to 24 months	The outcome will be measured as the duration of time from enrollment to progression of the subject's treated tumor(s)
Reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials	approx. 2 weeks	This will be recorded as numerical values for each of the shift/rotational directions and the vector composites of the directional shifts at the time of verification imaging.
Overall Survival	approx. 5 years	This outcome will be measured as the duration of time from the date of enrollment to the study to the date of death from any cause.
Change from Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Score	pre-SBRT and 1, 3, 6, and 12 months after the last treatment of SBRT	The MDASI-LC Module includes 22 questions to assess the severity of multiple lung cancer-related symptoms and the impact of these symptoms on daily functioning. Scores for each item range from 0 to 10, where 0 indicates no symptoms and 10 indicates worst possible symptoms.

Trial Locations

Locations (1)

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States