Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) for the Treatment of Central and Ultra-Central Early-Stage Non-Small Cell Lung Cancer

Trial Title: Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) for the Treatment of Central and Ultra-Central Early-Stage Non-Small Cell Lung Cancer

NCT ID: NCT05785845

Condition: Early Stage Non-small Cell Lung Cancer
Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
NSCLC
lung cancer
ultra-central lung cancer
SBRT
IGRT
adaptive radiotherapy
CT-guided radiotherapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Computed tomography-guided stereotactic adaptive radiotherapy
Description: Fractions will be delivered on consecutive business days.
Arm group label: Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR)

Other name: CT-STAR

Intervention type: Device
Intervention name: ETHOS
Description: ETHOS is a unique ring-gantry CT-guided linear accelerator notable for having an on-board cone beam CT (CBCT) imaging unit with improved definition and resolution to enable target and organ-at-risk contouring. It also has a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy.
Arm group label: Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR)

Summary: This study will evaluate the impact of CT-guided adaptive stereotactic radiotherapy (CT-STAR) to central and ultra-central early-stage non-small cell lung cancers on grade 3 or greater toxicity. Online adaptive radiation therapy was until recently only done clinically on an integrated MRI-guided system, but recently, Varian Medical Systems has created a CT-guided radiotherapy machine capable of online adaptive radiotherapy (ETHOS). The vast majority of stereotactic body radiotherapy (SBRT) for early-stage lung cancers is performed on a CT-guided machine rather than an MRI-guided machine, necessitating the evaluation of adaptive radiotherapy using ETHOS in this population. Historically, the non-adaptive, stereotactic treatment of central and ultra-central thoracic disease has been associated with unacceptable rates of grade 3+ toxicity. This has resulted in widespread adoption of a hypofractionated, less ablative 8-15 day treatment courses, with a baseline, one-year grade 3+ toxicity rate of 20%. Use of CT-STAR with daily, CT-guided plan adaptation to carefully spare adjacent organs-at-risk (OAR) in this setting may enable safe delivery of a shorter (5 fraction) and more ablative radiotherapy course.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically or radiographically diagnosed stage I-IIA (AJCC, 8th ed.) non-small cell lung cancer or mediastinal recurrent non-small cell lung cancer with plans to be treated with definitive intent SBRT alone. - Clinical AJCC stage I defined as stage 1A1 (T1a1N0M0, T1a tumor less than or equal to 1 cm), stage 1A2 (T1bN0M0, T1b tumor between 1 and 2 cm), and stage 1A3 (T1cN0M0, T1c tumor between 2 and 3 cm). - Clinical AJCC stage IB defined as T2aN0M0, T2a tumor between 3 and 4 cm. - Clinical AJCC stage IIA defined as T2bN0M0, T2b tumor between 4 and 5 cm. - Lesions must be defined as central or ultra-central according to the Hilus-trial13 criteria: - Central lesions are defined as lesions 1 cm or less from the trachea, carina, main bronchi, bronchus intermedius, or lobar bronchi. - Ultra-central lesions are defined as lesions touching the trachea, carina, main bronchi, bronchus intermedius, or lobar bronchi. Lesions that touch the esophagus, great vessels, or heart may also be included as ultra-central. - Tumor coverage is deemed adequate in simulation treatment planning as determined by the treating and study physicians. Specifically, the dose to 98% of the GTV must be greater than 45 Gy. - Note: patients with inadequate tumor coverage at simulation will be considered screen-failures and treated off-protocol as per institutional standard-of-care. *In a in silico analysis of these patients, only 1/6 patients screen-failed based on this inclusion criteria. - Patients should be able to hold their breath for 10 seconds. - Inoperable disease or patient has refused/declined surgery. - Deemed medically fit for SBRT by the treating physician. - At least 18 years of age. - Zubrod Performance Status 0-2 within 30 days prior to registration. - Appropriate stage for protocol entry based upon the following minimum diagnostic workup. - History/physical examination within 30 days prior to registration. - FDG-PET/CT scan and/or CT chest (with or without contrast) for staging within 60 days prior to registration. - Adequate bone marrow and hemostasis function determined no more than 30 days prior to registration, defined as follows: - Platelets ≥ 150,000 cells/mm3 - Hemoglobin ≥ 8 g/dl - Able to understand and willing to sign an IRB approved written informed consent. Exclusion Criteria: - Lesions appearing to extend through the bronchial or great vessel walls on CT imaging. - Prior or concurrent malignancies, unless the natural history of the prior or concurrent malignancy does not have the potential to interfere with the interpretation of the results of the study. - Patients with a pre-existing, active diagnosis of metastatic cancer. - Severe, active comorbidity, defined as follows: - Unstable angina, history of myocardial infarction and/or congestive heart failure requiring hospitalization within the last 6 months; - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; - Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. - Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by CT-guided SBRT. - Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of the start of SBRT.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Recruiting

Contact:
Last name: Pamela Samson, M.D., MPHS

Phone: 314-801-3806
Email: psamson@wustl.edu

Investigator:
Last name: Pamela Samson, M.D., MPHS
Email: Principal Investigator

Investigator:
Last name: Eric Laugeman, M.S.
Email: Sub-Investigator

Investigator:
Last name: Xiaodong Zhao, Ph.D.
Email: Sub-Investigator

Investigator:
Last name: Yi Huang, M.S.
Email: Sub-Investigator

Start date: April 10, 2023

Completion date: October 31, 2025

Lead sponsor:
Agency: Washington University School of Medicine
Agency class: Other

Collaborator:
Agency: Varian Medical Systems
Agency class: Industry

Source: Washington University School of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05785845
http://www.siteman.wustl.edu