Radiation Therapy Techniques for Lung Cancer

Overseen By Jenna Gregory, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Atrium Health

Must not be taking: Antibiotics, Steroids

Disqualifiers: Prior chest radiation, Active pulmonary infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

45 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are receiving systemic chemotherapy or other systemic agents, you must stop taking them during the SBRT treatments.

What data supports the effectiveness of the treatment Breath Hold SBRT, SGRT for lung cancer?

Research shows that using breath-hold techniques like deep inspiration breath-hold (DIBH) in lung cancer treatment helps reduce tumor movement during radiation, which can improve the accuracy of targeting the cancer. Studies also indicate that surface-guided radiation therapy (SGRT) can enhance the precision of treatment delivery by monitoring the patient's position, potentially leading to better outcomes. ^{1 2 3 4 5}

Is radiation therapy using techniques like Breath Hold SBRT and SGRT safe for lung cancer patients?

Radiation therapy techniques like Breath Hold SBRT and SGRT have been shown to be generally safe for lung cancer patients, with studies indicating high patient compliance and reduced doses to critical organs like the heart and lungs. However, tumors in ultra-central locations may require special safety considerations. ^{1 4 5 6 7}

How is the Breath Hold SBRT treatment for lung cancer different from other treatments?

Breath Hold SBRT for lung cancer is unique because it uses a technique called deep inspiration breath-hold (DIBH) to minimize tumor movement during radiation therapy, which helps in delivering precise doses to the tumor while reducing exposure to surrounding healthy tissues. This approach can lead to better targeting of the tumor and potentially fewer side effects compared to traditional methods that do not manage breathing motion as effectively. ^{1 4 5 6 8}

What is the purpose of this trial?

This is a pilot study designed to to provide data and experience comparing two different techniques of breath hold SBRT treatments. The first technique will include SGRT, but with the assistance of implanted fiducials. Subjects will be treated with a breath hold technique utilizing SGRT, but will also be imaged during treatment with fiducial match. The second technique will utilize SGRT for breath hold treatments without the assistance of implanted fiducials/continuous imaging.

Research Team

John Heinzerling, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 with certain types of lung cancer or tumors that move when they breathe. They must be able to follow the study plan and use effective birth control if needed. People can't join if they've had chest radiation before, have an active lung infection or pneumonitis, or were treated for pneumonitis within the last 15 days.

Inclusion Criteria

I am currently on chemotherapy or other treatments but can stop them for SBRT.

My tumor is 7 cm or smaller, confirmed or suspected to be cancer.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I am currently being treated for a lung infection or inflammation.

I have had radiation to the chest in the same area before.

I was treated for lung inflammation from a drug or therapy within the last 15 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SBRT treatment with or without fiducials for breath hold techniques

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Participants are monitored for overall survival and local control of treated tumors

up to 5 years

Treatment Details

Interventions

• Breath Hold SBRT
• SGRT

Trial Overview The study compares two ways to do SBRT (a type of radiation therapy) during breath holds for treating lung issues. One way uses SGRT with implanted markers called fiducials; the other just uses SGRT without these markers.

Participant Groups

Group I: Group 3 Experimental Treatment 1 Intervention

Breath hold SBRT with SGRT in combination with implanted fiducials

Group II: Group 2 Experimental Treatment 1 Intervention

Breath hold SBRT with SGRT

Group III: Group 1 Experimental Treatment 1 Intervention

Freebreathing SBRT with SGRT

Who Is Running the Clinical Trial?

Atrium Health

Lead Sponsor

Trials

122

Recruited

34,900+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Findings from Research

Stereotactic body radiotherapy (SBRT) for ultra-central lung tumors shows high efficacy, with pooled local control rates of 92% at 1 year and 89% at 2 years, based on a systematic review of 27 studies involving 1183 treated targets.

While SBRT is effective, it carries risks of severe toxicity, with a 6% incidence of grade 3-4 toxicities and a 4% incidence of treatment-related deaths, highlighting the importance of careful patient selection and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for Ultra-Central lung Tumors: A systematic review and Meta-Analysis and International Stereotactic Radiosurgery Society practice guidelines. Yan, M., Louie, AV., Kotecha, R., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Intrafraction target shift comparison using two breath-hold systems in lung stereotactic body radiotherapy. [2023]

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

Evaluation of deep inspiration breath-hold lung treatment plans with Monte Carlo dose calculation. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Deep inspiration breath hold in locally advanced lung cancer radiotherapy: validation of intrafractional geometric uncertainties in the INHALE trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Reproducibility of surface-based deep inspiration breath-hold technique for lung stereotactic body radiotherapy on a closed-bore gantry linac. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Tumor localization accuracy for high-precision radiotherapy during active breath-hold. [2020]

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

Clinical experience of volumetric-modulated flattening filter free stereotactic body radiation therapy of lesions in the lung with deep inspiration breath-hold. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for Ultra-Central lung Tumors: A systematic review and Meta-Analysis and International Stereotactic Radiosurgery Society practice guidelines. [2023]

8. Poland pubmed.ncbi.nlm.nih.gov

Tracking, gating, free-breathing, which technique to use for lung stereotactic treatments? A dosimetric comparison. [2023]