CT-Guided Stereotactic Radiotherapy for Lung Cancer

Recruiting at 1 trial location

Overseen By Pamela Samson, M.D., MPHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Metastatic cancer, Unstable angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for individuals with early-stage non-small cell lung cancer. A CT-guided system precisely targets cancer while sparing nearby healthy organs, potentially reducing harmful side effects. Known as Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR), this method is particularly relevant for tumors near vital structures like the trachea or heart. Individuals with inoperable lung cancer or those who refuse surgery, and can hold their breath for 10 seconds, might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that CT-guided stereotactic radiotherapy is safe for lung cancer treatment?

Research shows that CT-guided stereotactic adaptive radiotherapy (CT-STAR) is under study as a safe treatment for early-stage lung cancers. This method uses a precise radiation beam to target cancer cells and adjusts to changes in the patient's body during each session.

Previous studies on similar treatments, such as CT-guided adaptive radiation therapy, have found it generally well-tolerated by patients with other cancers, like liver cancer. These studies suggest that the treatment could reduce harm to nearby healthy organs, potentially lowering the risk of severe side effects.

Older versions of this radiotherapy, which did not adapt to the patient's body, have been linked to significant side effects when treating central lung tumors. The new method aims to address these issues by adjusting the treatment to the patient's condition each day. While this approach shows promise, detailed information on side effects for this specific treatment in lung cancer patients is still being gathered. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CT-Guided Stereotactic Radiotherapy for lung cancer because it offers a highly targeted approach that adapts to changes in the tumor's size and position. Unlike traditional radiotherapy, which often uses a fixed plan, this method uses computed tomography (CT) scans to adjust the radiation dose daily, based on the tumor's current location and shape. This precision helps to minimize damage to surrounding healthy tissue and could potentially improve treatment effectiveness and reduce side effects.

What evidence suggests that CT-guided stereotactic radiotherapy is effective for early-stage non-small cell lung cancer?

Research has shown that CT-guided stereotactic adaptive radiotherapy (CT-STAR), the treatment under study in this trial, offers a promising approach for early-stage non-small cell lung cancer. Traditional non-adaptive stereotactic treatments often lead to severe side effects, with about 20% of patients experiencing serious issues. CT-STAR aims to reduce these side effects by adjusting the treatment plan daily, based on changes in the patient's body. This method allows for more precise radiation delivery, potentially making it safer and more effective. Early results suggest that CT-STAR may provide a shorter and stronger treatment, possibly improving outcomes while reducing harm to nearby healthy organs. ^{1 2 3 6 7}

Who Is on the Research Team?

Pamela Samson, M.D., MPHS

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with early-stage non-small cell lung cancer that's inoperable or surgery-refused, and located centrally or ultra-centrally. Participants need good bone marrow function, the ability to hold their breath for 10 seconds, a specific performance status score, and no history of radiotherapy where SBRT will be applied. Pregnant or breastfeeding individuals are excluded.

Inclusion Criteria

My doctor says I'm fit for targeted radiation therapy.

My lung cancer is in the early stages or has returned in the chest area, and I plan to undergo targeted radiation therapy.

My doctors agree my tumor can be effectively targeted in treatment planning.

Exclusion Criteria

You have a serious, ongoing health problem.

Your CT scan shows that the lesions have spread into the walls of the airways or major blood vessels.

I have had cancer before, but it won't affect this study's results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CT-guided adaptive stereotactic radiotherapy (CT-STAR) with a prescription dose of 55 Gy in 5 fractions delivered on consecutive business days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on grade 3 or greater treatment-related toxicity

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR)

Trial Overview The study tests CT-guided stereotactic adaptive radiotherapy (CT-STAR) using ETHOS technology on patients with central/ultra-central lung cancers. It aims to reduce severe toxicity by adapting daily treatment plans to protect surrounding organs while delivering a potent short course of radiation.

How Is the Trial Designed?

Group I: Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) Experimental Treatment 2 Interventions

In this study, consenting and eligible patients will receive a prescription dose of 55 Gy in 5 fractions (when possible) delivered on consecutive business days with adaptation based on daily anatomic changes as per clinical standard of care.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

In a study of 5,809 adult blunt trauma patients with hypotension, undergoing CT scans was associated with a significant reduction in in-hospital mortality, suggesting a protective effect of CT in unstable patients.

Despite some concerns, the study found no clinically meaningful harmful effects of CT on survival, indicating that it can be a valuable diagnostic tool even in hemodynamically unstable trauma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography during initial management and mortality among hemodynamically unstable blunt trauma patients: a nationwide retrospective cohort study. Tsutsumi, Y., Fukuma, S., Tsuchiya, A., et al.[2018]

CT-STAR (cone beam computed tomography-guided stereotactic adaptive radiation therapy) was found to be highly feasible, successfully completing 95% of treatment fractions while significantly reducing organ-at-risk (OAR) constraint violations compared to non-adapted plans.

CT-STAR improved tumor coverage in 63% of fractions and maintained high-quality imaging, suggesting it could be a promising approach for treating abdominal oligometastases, although further clinical trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Silico Trial of Computed Tomography-Guided Stereotactic Adaptive Radiation Therapy (CT-STAR) for the Treatment of Abdominal Oligometastases. Schiff, JP., Stowe, HB., Price, A., et al.[2022]

In a study of 40 lung SBRT patients, adaptive planning significantly reduced radiation dose to organs-at-risk (OARs) compared to nonadaptive plans, indicating improved safety for surrounding tissues during treatment.

The effectiveness of adaptive planning was correlated with changes in tumor volume and distances to OARs, suggesting that larger tumor shrinkage during treatment can lead to better dosimetric outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive stereotactic body radiation therapy planning for lung cancer. Qin, Y., Zhang, F., Yoo, DS., et al.[2018]

The first reported case of cone beam CT-guided stereotactic adaptive radiotherapy (CT-STAR) for pancreatic cancer demonstrated successful treatment in a 61-year-old female patient, allowing for precise targeting while minimizing damage to critical organs.

CT-STAR effectively adhered to strict safety constraints, achieving all hard constraints for critical gastrointestinal structures across five treatment fractions, which would have been violated by the initial treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first reported case of a patient with pancreatic cancer treated with cone beam computed tomography-guided stereotactic adaptive radiotherapy (CT-STAR). Kim, M., Schiff, JP., Price, A., et al.[2023]

Nearly 43% of hospitalized women aged 50-75 who are current or former smokers are at intermediate to high risk for developing lung cancer, highlighting a significant population that could benefit from screening.

Despite the high risk, only 38% of these women had undergone a low-dose CT scan for lung cancer screening in the past year, indicating a gap in adherence to recommended screening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of hospitalized women at high-risk for developing lung cancer. Gnanaraj, J., Ijaz, SH., Khaliq, W.[2023]

Stereotactic body radiation therapy (SBRT) is an effective treatment for early-stage non-small cell lung cancer (NSCLC), providing precisely targeted radiation doses to tumors, especially for patients who cannot undergo surgery.

The review highlights the importance of SBRT in both medically inoperable cases and its potential role in operable early-stage NSCLC, indicating its growing significance in cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Early-Stage Lung Cancer. Maquilan, G., Timmerman, R.[2018]

In a study of 642 blunt trauma patients, the estimated risk of cancer death from CT radiation exposure was only 0.1%, indicating that the risk of radiation is relatively low compared to the risk of trauma mortality.

The findings suggest that in intermediate level trauma patients, especially older individuals, the risk of death from trauma is significantly higher than the risk from radiation, highlighting the need for careful consideration of CT scans in younger patients with less severe injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of trauma mortality and estimated cancer mortality from computed tomography during initial evaluation of intermediate-risk trauma patients. Laack, TA., Thompson, KM., Kofler, JM., et al.[2016]

In a study of 94 trauma patients undergoing computed tomography (CT) scans, nearly 48% experienced at least one adverse event (AE), indicating that such events are common during emergency CT procedures.

Patients who experienced AEs spent significantly more time away from the resuscitation bay, and factors like needing vasopressor support or ongoing transfusions were linked to a higher incidence of AEs, suggesting a need for improved protocols to enhance safety and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma Computed Tomography in the Modern Era: Not Always Quick and Safe. Ghafil, C., Matsushima, K., Chiba, H., et al.[2021]

CT-STAR (CBCT-guided stereotactic adaptive radiation therapy) was found to be feasible in 34 out of 35 simulated treatment fractions for patients with ultracentral thoracic cancers, effectively reducing dose to organs at risk while maintaining tumor coverage.

The study demonstrated that CT-STAR improved dosimetric outcomes compared to nonadaptive SBRT, with a mean workflow time of about 28 minutes, indicating its potential for safe and effective treatment in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective In Silico Evaluation of Cone-Beam Computed Tomography-Guided StereoTactic Adaptive Radiation Therapy (CT-STAR) for the Ablative Treatment of Ultracentral Thoracic Disease. Schiff, JP., Laugeman, E., Stowe, HB., et al.[2023]

In a study involving 10 patients with locally advanced non-small cell lung cancer (NSCLC), cone-beam CT (CB-CT) guided adaptive radiotherapy (ART) effectively tracked tumor changes, leading to significant reductions in the gross tumor volume (GTV) and planning target volumes (PTV) over the course of treatment.

Weekly plan adaptations using CB-CT improved the sparing of healthy lung tissue, reducing the lung's normal tissue complication probability (NTCP) from 15.2% to 10.0%, while maintaining treatment effectiveness, demonstrating the feasibility and benefits of this approach in radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cone-Beam-CT Guided Adaptive Radiotherapy for Locally Advanced Non-small Cell Lung Cancer Enables Quality Assurance and Superior Sparing of Healthy Lung. Hoegen, P., Lang, C., Akbaba, S., et al.[2022]

Lung stereotactic body radiation therapy (SBRT) is an effective treatment option for early-stage non-small cell lung cancer (NSCLC) and is increasingly being used for more advanced cases.

The review highlights current treatment recommendations and planning for SBRT, indicating its growing role in managing lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Stereotactic Body Radiation Therapy. Rehman, S., Roach, MC., Bradley, JD., et al.[2018]

In a pilot study involving 7768 individuals, integrating smoking cessation (SC) services with low-dose computed tomography screening led to a high acceptance rate of SC referrals, with 69.8% of smokers opting for in-hospital programs.

The one-year quit rate for participants was 15.5%, and significant improvements were noted in smoking behaviors, such as reduced cigarette consumption and increased quit attempts, indicating the effectiveness of the integrated approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Smoking Cessation Into Low-Dose Computed Tomography Lung Cancer Screening: Results of the Ontario, Canada Pilot. Evans, WK., Tammemägi, MC., Walker, MJ., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05785845?tab=table

Computed Tomography-Guided Stereotactic Adaptive ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10188549/

Prospective In Silico Evaluation of Cone-Beam Computed ... We conducted a prospective, in silico study to evaluate the feasibility of cone-beam computed tomography (CBCT)-guided stereotactic adaptive radiation therapy ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625002482

Computed Tomography Guided Online Adaptive ... This study investigates the radiation dose in abdominal and pelvic lymph node oligometastases (AP LN) and gastrointestinal organs (GIOs) of patients

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11262774/

The First Reported Case of Treating the Ultra-Central Thorax ... We describe the first reported case of cone beam computed tomography (CBCT)-guided stereotactic adaptive radiotherapy (CT-STAR) in the treatment of ultra- ...

5. redjournal.org redjournal.org/article/S0360-3016(25)06202-9/fulltext

Lessons From the SUNSET Trial Methods and Materials. Five institutions enrolled patients with ultracentral lung cancer, cT1-3N0M0, and all received 60 Gy in 8 fractions.

6. redjournal.org redjournal.org/article/S0360-3016(25)00285-8/abstract

Computed Tomography-Guided Online Adaptive ... Purpose. We present a computed tomography-guided online adaptive radiation therapy (CT-ART) experience in liver stereotactic body radiation therapy (SBRT).

7. ctv.veeva.com ctv.veeva.com/study/computed-tomography-guided-stereotactic-adaptive-radiotherapy-ct-star-for-the-treatment-of-central

Computed Tomography-Guided Stereotactic Adaptive ... This study will evaluate the impact of CT-guided adaptive stereotactic radiotherapy (CT-STAR) to central and ultra-central early-stage ...