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

April 16, 2024 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pamela Samson, M.D., MPHS
  • Phone Number: 314-801-3806
  • Email: psamson@wustl.edu

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • Eric Laugeman, M.S.
        • Contact:
        • Principal Investigator:
          • Pamela Samson, M.D., MPHS
        • Sub-Investigator:
          • Xiaodong Zhao, Ph.D.
        • Sub-Investigator:
          • Yi Huang, M.S.
        • Sub-Investigator:
          • Joshua Schiff, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 or great vessels 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR)
In this study, consenting and eligible patients will receive a prescription dose of 55 Gy in 5 fractions delivered on consecutive business days with adaptation based on daily anatomic changes as per clinical standard of care.
Radiation: Computed tomography-guided stereotactic adaptive radiotherapy
Fractions will be delivered on consecutive business days.
Other Names:
  • CT-STAR
Device: ETHOS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of grade 3 or greater toxicity
Time Frame: 12 months post-completion of treatment (estimated to be 12 months and 5 days)
-Toxicity graded per CTCAE version 5.
12 months post-completion of treatment (estimated to be 12 months and 5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Varian Medical Systems

Investigators

  • Principal Investigator: Pamela Samson, M.D., MPHS, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202302003

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

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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