Low-Dose SBRT for Lung Cancer

Recruiting at 5 trial locations

Overseen By Henry S. Park, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Yale University

Disqualifiers: Prior radiotherapy, Infections, Cardiac disease, 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: 9

Duration: 1 week

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating lung cancer using a precise radiation therapy called SBRT (Stereotactic Body Radiotherapy). The researchers aim to determine if a lower dose of radiation, administered in three treatments, effectively targets tumors near sensitive chest areas like the bronchial tree, major blood vessels, or the heart. Individuals with centrally located lung tumors that are 5 cm or smaller may be suitable candidates for this study. The primary focus is to assess the safety and effectiveness of this treatment for these specific tumor types. As a Phase 1, Phase 2 trial, the study seeks to understand how the treatment works in participants and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

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

What prior data suggests that this 45 Gray (Gy) regimen is safe for treating centrally located thoracic tumors?

Research has shown that stereotactic body radiotherapy (SBRT), like the 45 Gray (Gy) treatment used in this trial, has been studied before. Studies have found that this treatment is generally safe for patients with lung tumors. For instance, one study found that SBRT is well-tolerated by patients with early-stage non-small cell lung cancer (NSCLC), with manageable side effects. Another study reported that patients with lung tumors who received SBRT experienced good long-term safety and effectiveness, even if they were not healthy enough for surgery.

However, when SBRT is used for tumors in very central parts of the lung, the safety information is less clear. Some reports suggest potential risks, but these are still under investigation. Overall, while SBRT is a promising treatment, especially for early-stage and some central lung tumors, patients should be aware that more research is needed on its safety for very central tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the low-dose SBRT (Stereotactic Body Radiotherapy) for lung cancer because it uses a de-escalated 45 Gray regimen delivered in just three fractions. Unlike standard lung cancer treatments that often involve higher radiation doses over longer periods, this method aims to minimize exposure while still effectively targeting cancer cells. By potentially reducing side effects and treatment time, this approach offers a promising alternative for patients, making it an innovative step forward in lung cancer care.

What evidence suggests that this 45 Gy SBRT regimen is effective for lung cancer?

Research has shown that stereotactic body radiotherapy (SBRT) effectively treats early-stage non-small cell lung cancer (NSCLC). Studies have found that SBRT can control cancer in its original location and often outperforms traditional radiotherapy. Specifically, treatment plans with doses greater than 100 Gray (Gy) tend to reduce the risk of recurrence and may extend patient survival. This trial tests the effectiveness and safety of a 45 Gy dose for tumors in sensitive chest areas. Overall, SBRT is considered a promising treatment option with a strong track record of success. ^{1 5 6 7 8}

Who Is on the Research Team?

Henry S. Park

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-small cell lung cancer that's centrally located and no larger than 5 cm. They should be relatively fit (ECOG 0-2), able to consent, not pregnant or breastfeeding, free of serious infections, significant heart disease, prior radiotherapy in the area, or lung fibrosis.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

Patients must sign a study-specific consent form

My lung tumor is 5 cm or smaller and located in the center of my lung.

Exclusion Criteria

May not be pregnant or lactating

I've had radiation before on the same area where my current cancer is.

I do not have any ongoing infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy for centrally located thoracic tumors

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

Up to 10 years

Regular visits every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• 45 Gray (Gy) regimen

Trial Overview The study is testing a reduced dose of stereotactic body radiotherapy (SBRT) at 45 Gray delivered in three sessions for treating central lung tumors. The goal is to see if lower doses are effective and possibly lead to fewer side effects.

How Is the Trial Designed?

Group I: 45 Gy Experimental Treatment 1 Intervention

Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.

45 Gray (Gy) regimen is already approved in United States, European Union, Japan, Canada for the following indications:

Approved in United States as SBRT for:

• Early-stage non-small cell lung cancer
• Lung metastases

Approved in European Union as SABR for:

• Early-stage non-small cell lung cancer
• Lung metastases

Approved in Japan as SBRT for:

• Early-stage non-small cell lung cancer
• Lung metastases

Approved in Canada as SABR for:

• Early-stage non-small cell lung cancer
• Lung metastases

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) using 8-12 Gy daily fractions over five treatments resulted in high local control rates of 93% at 1 year and 88% at 2 years for patients with oligometastatic lung cancer, indicating its efficacy in managing this condition.

The treatment was found to be safe, with no reported cases of symptomatic pneumonitis, and most local failures occurred within the first 12 months, particularly in patients with colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local control rates with five-fraction stereotactic body radiotherapy for oligometastatic cancer to the lung. Singh, D., Chen, Y., Hare, MZ., et al.[2022]

Stereotactic Ablative Radiotherapy (SABR) for central and ultra-central lung tumors shows promising outcomes, with median overall survival of 46 months and disease-free survival of 33 months among 137 patients treated between 2009 and 2016.

While central tumors had a better prognosis (median OS of 57 months) compared to ultra-central tumors (37 months), both types had high local control rates (95% at 1 year and 81% at 2 years) and relatively low severe toxicity rates (7.3% grade 3-5 toxicities).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-adapted stereotactic ablative radiotherapy for central and ultra-central lung tumours. Lenglet, A., Campeau, MP., Mathieu, D., et al.[2020]

In a study of 53 patients with lung tumors ≥5 cm treated with SABR, 30% experienced severe toxicity (grade ≥3), highlighting the need for improved treatment planning to reduce risks.

Using a knowledge-based planning model, researchers found that nearly 50% of the treatment plans for patients with severe toxicity could have been improved, particularly in terms of lung dose exposure, suggesting that model-based quality assurance could enhance safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge-Based Planning for Identifying High-Risk Stereotactic Ablative Radiation Therapy Treatment Plans for Lung Tumors Larger Than 5 cm. Hof, SV., Delaney, AR., Tekatli, H., et al.[2019]

In a study of 114 early-stage non-small cell lung cancer (NSCLC) patients, those treated with stereotactic body radiation therapy (SBRT) at a dose of 55 Gy in five fractions showed significantly better overall survival (OS) and local control rates compared to those treated with 50 Gy, with a notable improvement in three-year control rates.

The 55 Gy treatment group had a three-year local control rate of 96.6% compared to 66.3% for the 50 Gy group, indicating that higher doses of SBRT can enhance treatment effectiveness for patients who are medically inoperable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Institution Experience of Stereotactic Body Radiation Therapy in Non-small Cell Lung Cancer: Comparison of Two Dose Regimes and a Perspective on Ideal Dose Regimens. Nittala, MR., Duggar, WN., Mundra, E., et al.[2021]

In a study of 180 patients with stage I non-small-cell lung cancer, a stereotactic body radiotherapy (SBRT) regimen with higher doses (44, 48, and 52 Gy) and longer intervals (≥3 days) resulted in a 5-year overall survival rate of 52.2%, and 66% for operable patients, indicating promising efficacy.

The treatment showed an 86% local control rate for tumors ≤3 cm and a 73% rate for tumors >3 cm, with manageable toxicity levels, as only 13% of patients experienced grade 2 or higher radiation pneumonitis, suggesting that the protocol is both effective and relatively safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy using a radiobiology-based regimen for stage I non-small-cell lung cancer: five-year mature results. Shibamoto, Y., Hashizume, C., Baba, F., et al.[2022]

In a study of 300 patients with stage I non-small cell lung cancer treated with stereotactic ablative body radiotherapy (SABR), the treatment showed promising long-term local control and survival rates, with overall survival rates of 83% at 1 year and 37% at 4 years.

The treatment was associated with low toxicity, as no severe grade 4 or 5 adverse effects were reported, indicating that SABR is a safe and effective option for patients with this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term outcome after 48 Gy stereotactic ablative body radiotherapy for peripheral stage I non-small cell lung cancer. Dubaere, E., Goffaux, M., Wanet, M., et al.[2020]

In a study of 180 patients with stage I nonsmall cell lung cancer, a stereotactic body radiotherapy (SBRT) regimen with higher doses (44 Gy, 48 Gy, and 52 Gy) tailored to tumor size resulted in a 3-year overall survival rate of 69% and a local control rate of 86% for tumors ≤3 cm.

The treatment was associated with a manageable safety profile, with only 13% of patients experiencing grade ≥2 radiation pneumonitis, indicating that the higher dose regimen can be effective while maintaining acceptable toxicity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy using a radiobiology-based regimen for stage I nonsmall cell lung cancer: a multicenter study. Shibamoto, Y., Hashizume, C., Baba, F., et al.[2022]

In a study of 44 patients with early-stage non-small cell lung cancer (NSCLC) treated with a single dose of 30 Gy stereotactic body radiotherapy (SBRT), the 3- and 5-year local progression-free survival rates were both 87.8%, indicating high local control over time.

The treatment was well-tolerated, with only 4.6% of patients experiencing grade 3 pneumonitis, suggesting that SBRT at this dosage is a safe option for patients who cannot undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term results of single high dose Stereotactic Body Radiotherapy in the treatment of primary lung tumors. Nicosia, L., Reverberi, C., Agolli, L., et al.[2021]

The iSABR trial demonstrated that individualized stereotactic ablative radiotherapy (SABR) for lung tumors resulted in high local control rates, with freedom from local recurrence at 1 year ranging from 94% to 97% across different patient groups.

The trial showed a low incidence of severe toxic effects (only 5%), indicating that personalized dosing strategies can minimize risks while maintaining effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. Gensheimer, MF., Gee, H., Shirato, H., et al.[2023]

The TROG 13.01/ALTG 13.001 clinical trial is investigating the safety and efficacy of single versus multi-fraction stereotactic ablative body radiotherapy (SABR) for lung tumors in 84 patients with up to three metastases, aiming to determine the best treatment approach for pulmonary oligometastases.

The study will compare a single high dose of 28Gy to a total of 48Gy delivered in four fractions, assessing not only safety but also quality of life, survival rates, and potential cost implications of each treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). Siva, S., Kron, T., Bressel, M., et al.[2022]

In a study of 39 patients with 45 lung lesions treated with stereotactic ablative body radiotherapy (SBRT), local progression-free survival rates were high, with 90.5% at 1 year and 80.5% at 2 years, indicating effective tumor control.

The treatment was well-tolerated with only mild acute side effects, suggesting that the moderate dose schedules of 35 Gy (5 fractions) or 37.5 Gy (3 fractions) are safe and effective for managing non-small cell lung cancer and metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. Duncker-Rohr, V., Nestle, U., Momm, F., et al.[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]

Citations

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A systematic review of outcomes following stereotactic ... This systematic review considers the evidence supporting the use of SABR in early-stage NSCLC, reported toxicity rates, the use of SABR in centrally located ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043889/

A Population-based Study of the Effectiveness of Stereotactic ... Stereotactic ablative radiotherapy (SABR) is a promising option for non-operated early-stage non-small cell lung cancer (NSCLC) compared to conventional ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1556086419303156

Safety and Effectiveness of Stereotactic Ablative ... In this study, we systematically reviewed all published studies to report outcomes and identify trends in the safety and effectiveness of SABR for patients with ...

4. por-journal.com por-journal.com/journals/pathology-and-oncology-research/articles/10.3389/pore.2024.1611709/full

Stereotactic body radiotherapy in lung cancer Compared to conventional radiotherapy, SBRT with BED >100 Gy reduces local failure and may also increase overall survival [45, 47]. In 2007, ...

5. nature.com nature.com/articles/s41598-019-51900-8

Long term results of single high dose Stereotactic Body ... The results of our study indicated a high local control, survival and tolerability after a long-term follow-up with the use of SBRT 30 Gy single dose.

6. redjournal.org redjournal.org/article/S0360-3016(25)06209-1/abstract

5-year survival and safety of stereotactic ablative ... The 5-year outcomes of XXXX trial confirm robust and sustained benefit in terms of safety and effectiveness of SAbR in LA-NSCLC patients unfit ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3460596/

Stereotactic ablative body radiotherapy (SABR) for primary ... This article discusses SABR, a technological breakthrough in radiotherapy, for the treatment of primary and secondary lung tumours.

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2778658

Evaluation of Safety of Stereotactic Body Radiotherapy for ... Standard ablative radiation schedules appear to be safe for patients with oligometastatic disease with 3 to 4 metastases or 2 metastases in close proximity to ...