Low-Dose SBRT for Lung Cancer

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

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.

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 data supports the effectiveness of the treatment Low-Dose SBRT for Lung Cancer?

Research shows that Stereotactic Body Radiotherapy (SBRT) is effective for early-stage non-small cell lung cancer, improving tumor control and survival rates. Studies indicate that higher doses, like 55 Gy, result in better outcomes compared to lower doses, suggesting that even moderate doses like 45 Gy could be beneficial. ^{1 2 3 4 5}

Is low-dose SBRT (Stereotactic Body Radiotherapy) safe for treating lung cancer?

Stereotactic Ablative Radiotherapy (SABR) is generally safe for treating small lung tumors, but it can cause serious side effects, especially for larger tumors or those near critical structures. Studies show that careful planning and dose adjustments can help manage these risks. ^{3 6 7 8 9}

How does the 45 Gy SBRT treatment for lung cancer differ from other treatments?

The 45 Gy SBRT treatment for lung cancer is unique because it uses a lower dose compared to the more common regimens like 48 Gy or higher, and it is delivered in a precise manner over a few sessions, which helps target the tumor while minimizing damage to surrounding healthy tissue. ^{1 2 10 11 12}

Research Team

Henry S. Park

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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 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 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 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]

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]

References

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

Stereotactic body radiotherapy using a radiobiology-based regimen for stage I nonsmall cell lung cancer: a multicenter study. [2022]

2. United States 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. [2021]

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

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. [2023]

4. 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]

5. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Risk-adapted stereotactic ablative radiotherapy for central and ultra-central lung tumours. [2020]

7. England 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). [2022]

8. United States 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. [2019]

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

Long term outcome after 48 Gy stereotactic ablative body radiotherapy for peripheral stage I non-small cell lung cancer. [2020]

10. United States 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Long term results of single high dose Stereotactic Body Radiotherapy in the treatment of primary lung tumors. [2021]

12. China pubmed.ncbi.nlm.nih.gov

Local control rates with five-fraction stereotactic body radiotherapy for oligometastatic cancer to the lung. [2022]