CT-Guided Stereotactic Radiotherapy for Lung Cancer

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment CT-Guided Stereotactic Radiotherapy for Lung Cancer?

Research suggests that CT-guided stereotactic adaptive radiotherapy (CT-STAR) can improve the precision of radiation delivery, reducing exposure to healthy organs while effectively targeting tumors. This approach has shown promising results in other cancers, like pancreatic cancer, and studies indicate it may offer better protection for healthy lung tissue in lung cancer treatment. ^{1 2 3 4 5}

Is CT-Guided Stereotactic Radiotherapy generally safe for humans?

The research articles provided do not contain specific safety data for CT-Guided Stereotactic Radiotherapy or its related terms in humans. ^{6 7 8 9 10}

How is CT-STAR treatment different from other treatments for lung cancer?

CT-STAR is unique because it uses real-time imaging to adapt the radiation treatment to the patient's anatomy each day, potentially reducing damage to nearby healthy organs while maintaining effective tumor coverage, unlike traditional nonadaptive stereotactic body radiation therapy (SBRT). ^{1 2 3 11 12}

Research Team

Pamela Samson, M.D., MPHS

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

I am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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). [2023]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

In Silico Trial of Computed Tomography-Guided Stereotactic Adaptive Radiation Therapy (CT-STAR) for the Treatment of Abdominal Oligometastases. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Adaptive stereotactic body radiation therapy planning for lung cancer. [2018]

5. Switzerland 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Computed tomography during initial management and mortality among hemodynamically unstable blunt trauma patients: a nationwide retrospective cohort study. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Integrating Smoking Cessation Into Low-Dose Computed Tomography Lung Cancer Screening: Results of the Ontario, Canada Pilot. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of trauma mortality and estimated cancer mortality from computed tomography during initial evaluation of intermediate-risk trauma patients. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Prevalence of hospitalized women at high-risk for developing lung cancer. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Trauma Computed Tomography in the Modern Era: Not Always Quick and Safe. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Early-Stage Lung Cancer. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Lung Stereotactic Body Radiation Therapy. [2018]