Post-Surgery Stereotactic Body Radiation for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Pregnancy, Prior radiation, Contraindication to SBRT, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1-2 weeks

50 Participants Needed

Trial Summary

Do I need to stop my current medications for this 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 Stereotactic Body Radiation Therapy, Stereotactic Ablative Radiotherapy (SABR), CyberKnife for lung cancer?

Research shows that Stereotactic Ablative Radiotherapy (SABR), especially using the CyberKnife system, is effective for treating early-stage non-small cell lung cancer (NSCLC), offering high rates of tumor control with acceptable side effects. It is particularly beneficial for patients who cannot undergo surgery, providing a precise and non-invasive treatment option. ^{1 2 3 4 5}

Is stereotactic body radiation therapy (SBRT) safe for lung cancer patients?

Stereotactic body radiation therapy (SBRT), including treatments using the CyberKnife system, has been shown to have acceptable safety levels with some risk of serious complications. It is important to have strategies in place to reduce these risks, but overall, it is considered safe for treating lung cancer. ^{2 3 4 6 7}

How is post-surgery stereotactic body radiation for lung cancer different from other treatments?

Post-surgery stereotactic body radiation (also known as stereotactic ablative body radiotherapy or SABR) is unique because it delivers high doses of radiation with precision over a few sessions, making it a non-invasive option for patients who cannot undergo surgery. It is particularly effective for early-stage non-small cell lung cancer, offering high local tumor control with minimal side effects, and is often used when surgery is not possible. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial studies the side effects of single fraction stereotactic body radiation therapy after surgery in treating patients with non-small cell lung cancer. Standard radiation for lung cancer involves delivering small doses of daily radiation for several weeks. However, this technique has resulted in inferior outcomes compared to surgery and is associated with damage to surrounding normal lung. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving stereotactic body radiation therapy in fewer treatment sessions (single fraction) may kill tumor cells and cause less damage to normal tissue.

Research Team

Anurag K. Singh

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for adults with non-small cell lung cancer who've had surgery to remove it but might still have some cancer cells near the edges of where the tumor was or in certain lymph nodes. They should be able to do most activities on their own (ECOG <=2) and agree to birth control if they can have children. People can't join if they're pregnant, nursing, had prior radiation in that area, can't stay still for treatment, or are unable to follow study rules.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I had surgery for lung cancer with specific conditions met regarding the margins and lymph nodes.

I am using or willing to use birth control or practice abstinence.

Exclusion Criteria

Unwilling or unable to follow protocol requirements

My doctor thinks I can't safely join the study.

I had a partial lung surgery without full lymph node examination.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT beginning at least 2 weeks after surgical resection

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 5 and 12 weeks, then periodically up to 5 years

Treatment Details

Interventions

• Stereotactic Body Radiation Therapy

Trial Overview The trial tests a single high-dose radiation treatment called Stereotactic Body Radiation Therapy (SBRT) after lung cancer surgery. It's designed to see if one big dose can kill leftover cancer cells without harming too much healthy tissue. Patients will also fill out questionnaires about their quality of life before and after treatment.

Participant Groups

Group I: Treatment (SBRT) Experimental Treatment 3 Interventions

Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Findings from Research

Stereotactic ablative body radiotherapy (SABR) is now the standard treatment for early-stage non-small-cell lung cancer (NSCLC) in patients who cannot undergo surgery, highlighting its efficacy in this patient population.

The review also discusses the safety profile of SABR, including reported toxicity rates, and explores its potential use in combination with other therapies for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. Murray, P., Franks, K., Hanna, GG.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

In a study of 73 patients with metastatic lung tumors treated using the CyberKnife system, stereotactic ablative body radiotherapy (SABR) demonstrated high effectiveness, achieving a 2-year local control rate of 89.1% and an overall survival rate of 71.3%.

The treatment was associated with acceptable toxicity levels, with only two cases of grade 2 or higher radiation pneumonitis, indicating that SABR with a central high dose is a safe option for managing metastatic lung tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]

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

CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

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

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]

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

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. [2023]