Trial Summary
What is the purpose of this trial?This trial tests if using AI to decide radiation doses can improve treatment for lung cancer patients. The AI aims to make radiation therapy more precise and effective, reducing the chance of cancer returning. The study will see if this approach helps patients live longer without their cancer getting worse and if it is safe and practical to use in real-life settings.
Is Stereotactic Body Radiation Therapy a promising treatment for lung cancer?Yes, Stereotactic Body Radiation Therapy (SBRT), also known as Stereotactic Ablative Radiotherapy (SABR) or CyberKnife, is a promising treatment for lung cancer. It offers high precision in targeting tumors, leading to high rates of local tumor control with minimal side effects. It is especially beneficial for patients who cannot undergo surgery, providing a non-invasive option with a short treatment duration.12456
What data supports the idea that AI-Directed Radiation Therapy for Lung Cancer is an effective treatment?The available research shows that AI-Directed Radiation Therapy, specifically using the CyberKnife system, is effective for treating early-stage non-small cell lung cancer. Studies highlight high rates of local tumor control, meaning the cancer is effectively managed in the area it started, with acceptable levels of side effects. This treatment is particularly beneficial for patients who cannot undergo surgery. Compared to traditional radiation therapy, this method offers better outcomes for those who are inoperable or choose not to have surgery. The CyberKnife system's precision allows for a shorter treatment period, making it a practical option for many patients.12456
What safety data exists for AI-directed radiation therapy for lung cancer?The safety data for AI-directed radiation therapy, specifically using the CyberKnife system for stereotactic ablative radiotherapy (SABR), indicates acceptable toxicity levels and high rates of local tumor control. Studies have shown its effectiveness and safety in treating early-stage non-small-cell lung cancer and metastatic lung tumors, with the advantage of a short treatment course. The CyberKnife system's unique capabilities make it suitable for treating tumors that move with breathing, such as lung tumors.13456
Do I need to stop taking my current medications for this trial?The trial does not specify if you need to stop all current medications. However, if you are on targeted therapies, you must pause them 3 days before and restart at least 3 days after the radiation therapy. Concurrent immunotherapy (if not investigational) and COVID-19 vaccinations are allowed.
Eligibility Criteria
Adults (18+) with primary lung cancer or a few metastatic tumors in the lungs, able to perform daily activities (ECOG 0-2), and not pregnant can join. They must understand and sign consent. Excluded are those with prior overlapping radiotherapy, unresolved thoracic toxicities from past treatments, concurrent investigational drugs, other interfering malignancies, or uncontrolled illnesses.Inclusion Criteria
I am 18 years old or older.
I can take care of myself and am up and about more than half of my waking hours.
I can understand and am willing to sign the consent form.
Exclusion Criteria
I am not currently on any experimental cancer treatments or strong chemotherapy.
I am not pregnant or nursing.
I have had radiotherapy in the same area more than once.
Treatment Details
The RAD-AI study is testing if AI can improve dose recommendations during SBRT for lung cancer treatment. It aims to see if personalized AI predictions lead to better outcomes by reducing local recurrence of the disease while minimizing damage to healthy tissue.
1Treatment groups
Experimental Treatment
Group I: Treatment (AI-directed analysis, SBRT)Experimental Treatment7 Interventions
Patients undergo radiation planning with AI-directed analysis for dose recommendations with Deep Profiler + iGray software on study. Patients then undergo SBRT on study. Patients also undergo PET, CT, MRI, and/or x-ray imaging during screening and follow-up.
Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇦🇺 Approved in Australia as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
Find a clinic near you
Research locations nearbySelect from list below to view details:
Northwestern UniversityChicago, IL
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
Varian Medical SystemsIndustry Sponsor
National Cancer Institute (NCI)Collaborator
References
CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]Stereotactic ablative radiotherapy (SABR) has emerged as a promising treatment for early stage non-small cell lung cancer, particularly for patients unable to tolerate surgical resection. High rates of local tumor control have been demonstrated with acceptable toxicity and the practical advantage of a short course of treatment. The CyberKnife image-guided robotic radiosurgery system has unique technical characteristics that make it well suited for SABR of tumors that move with breathing, including lung tumors. We review the qualities of the CyberKnife platform for lung tumor SABR, and provide a summary of clinical data using this system specifically.
Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]Stereotactic ablative radiotherapy (SABR), otherwise known as stereotactic body radiation therapy (SBRT), is an external beam treatment modality that offers the ability to deliver with high precision large doses of radiation over a limited number of fractions. SABR is currently a standard of care in the treatment of early-stage primary non-small cell lung cancers (NSCLCs) that are medically inoperable and for metastases in many anatomical locations. To date, local control and toxicity parameters with SABR for early-stage NSCLCs are comparable to those found in reports of experiences with surgical resection. It is increasingly apparent that some patients with borderline resectable lung primaries are also looking to SABR as a noninvasive means of therapy. However, randomized comparisons have not been completed to assess survival in operable patients. This review summarizes the advanced technology and radiation concepts that have helped clinicians optimize the use of stereotactic ablative therapies for lung cancer, with an emphasis on the rationale for future continued use of this advanced treatment modality.
Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. [2022]Stereotactic ablative radiation therapy (SABR) is increasingly used to treat lung oligometastases. We set out to determine the safety and efficacy of this approach and to identify factors associated with outcomes.
Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]Stereotactic ablative body radiotherapy (SABR) provides a superior non-small cell lung cancer (NSCLC) treatment option when compared to conventional radiotherapy for patients deemed inoperable or refusing surgery. This study retrospectively analyzed the rates of tumor control and toxicity following SABR treatment (Cyberknife system) of primary early-stage NSCLC in a community setting.
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]We evaluated the effectiveness and safety of stereotactic ablative radiotherapy (SABR) delivered using Cyberknife in patients with stage I non-small-cell lung cancer.
Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. [2023]The CyberKnife system features a robotically-positioned linear accelerator to deliver real-time image-guided stereotactic ablative body radiotherapy (SABR). It achieves steep dose gradients using irradiation from hundreds of different directions and increases the central dose of the gross tumor volume (GTV) without increasing the marginal dose to the planning target volume. We evaluated the effectiveness and safety of SABR with a central high dose using CyberKnife for metastatic lung tumors.