CT-guided adaptive radiotherapy for early-stage lung cancer
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 is testing a new type of radiation therapy for early-stage lung cancer to see if it can reduce severe side effects compared to standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT05785845 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of computed tomography-guided adaptive stereotactic radiotherapy (CT-STAR) for treating central and ultra-central early-stage non-small cell lung cancer (NSCLC). The approach utilizes a new CT-guided radiotherapy machine, ETHOS, which allows for online adaptive radiotherapy, a method previously limited to MRI-guided systems. The study aims to assess the impact of this technique on reducing severe toxicity (grade 3 or greater) associated with traditional treatment methods. By focusing on a population that has historically faced high toxicity rates, this study seeks to improve treatment outcomes for patients with early-stage lung cancer.
Who should consider this trial
Good fit: Ideal candidates include individuals with stage I-IIA non-small cell lung cancer, specifically those with central or ultra-central lesions.
Not a fit: Patients with advanced-stage lung cancer or those not meeting the specific criteria for central or ultra-central lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment-related toxicity for patients with early-stage lung cancer.
How similar studies have performed: While adaptive radiotherapy has been explored in other contexts, this specific application using CT-guided technology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Pamela Samson, M.D., MPHS — Washington University School of Medicine
- Study coordinator: Pamela Samson, M.D., MPHS
- Email: psamson@wustl.edu
- Phone: 314-801-3806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.