Radiation Schedules for Early-Stage Lung Cancer

Overseen By Deepinder Singh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Central tumors, Metastases, Prior malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot receive other cancer treatments like chemotherapy or surgery while participating in this trial.

What data supports the effectiveness of this treatment for early-stage lung cancer?

Research shows that stereotactic body radiotherapy (SBRT) is effective for early-stage lung cancer, offering better local control and survival rates compared to traditional radiation therapy. Studies also indicate that SBRT is safe and feasible for patients who cannot undergo surgery, with ongoing trials exploring optimal dosing. ^{1 2 3 4 5}

Is radiation therapy safe for early-stage lung cancer?

Radiation therapy, including Stereotactic Body Radiation Therapy (SBRT) and Stereotactic Ablative Radiotherapy (SABR), is generally safe for early-stage lung cancer, with low risk of severe side effects, especially for tumors located away from sensitive structures. However, there is a higher risk of severe side effects for tumors near critical areas like the bronchial tree or mediastinum. ^{2 6 7 8 9}

How is the treatment 'Radiation Schedules for Early-Stage Lung Cancer' different from other treatments for this condition?

This treatment uses advanced radiation techniques like Stereotactic Ablative Radiation Therapy (SABR) and Intensity Modulated Radiation Therapy (IMRT) to precisely target early-stage lung cancer, minimizing damage to surrounding healthy organs. It offers a non-surgical option for patients who are not candidates for surgery, with the potential for improved local control and survival rates compared to traditional radiation methods. ^{1 2 3 10 11}

Eligibility Criteria

This trial is for adults with early-stage non-small cell lung cancer, specifically certain types of squamous cell carcinoma, adenocarcinoma, and others without spread to lymph nodes or other organs. Participants should be in fair health and not pregnant. They must agree to use contraception and have no recent history of other cancers or prior chest radiation.

Inclusion Criteria

My lymph nodes in the chest area are normal size and show no signs of cancer on a PET scan.

My scans show large lymph nodes but biopsies confirm they are not cancerous.

My lung cancer is one of the specified types (e.g., squamous, adenocarcinoma).

Exclusion Criteria

I will be receiving cancer treatment alongside this study.

My cancer has spread to other parts of my body.

I have been diagnosed with more than one lung cancer at the same time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic body radiotherapy in either 3 or 5 fractions

1-2 weeks

Follow-up

Participants follow up with their radiation oncologist to monitor side effects and treatment outcomes

1 year

Long-term follow-up

Participants are monitored for overall survival and disease-free survival

3 years

Treatment Details

Interventions

• Radiation therapy-3 fractions
• Radiation therapy-5 fractions

Trial Overview The study compares two schedules of radiation therapy for treating lung cancer: one group will receive three fractions (doses) while the other gets five fractions. The aim is to see if side effects differ between these two treatment schedules.

Participant Groups

Group I: Stereotactic body radiotherapy- 3 fractions Active Control 1 Intervention

Group II: Stereotactic body radiotherapy- 5 fractions Active Control 1 Intervention

Radiation therapy-3 fractions is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation therapy for:

• Lung cancer
• Non-small cell lung cancer (NSCLC)
• Small cell lung cancer (SCLC)

Approved in United States as Radiation therapy for:

• Lung cancer
• Non-small cell lung cancer (NSCLC)
• Small cell lung cancer (SCLC)

Approved in Canada as Radiation therapy for:

• Lung cancer
• Non-small cell lung cancer (NSCLC)
• Small cell lung cancer (SCLC)

Approved in Japan as Radiation therapy for:

• Lung cancer
• Non-small cell lung cancer (NSCLC)
• Small cell lung cancer (SCLC)

Approved in China as Radiation therapy for:

• Lung cancer
• Non-small cell lung cancer (NSCLC)
• Small cell lung cancer (SCLC)

Approved in Switzerland as Radiation therapy for:

• Lung cancer
• Non-small cell lung cancer (NSCLC)
• Small cell lung cancer (SCLC)

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Findings from Research

A review of 80 patients treated with single-fraction lung stereotactic body radiation therapy (SBRT) showed that both 30 Gy and 34 Gy doses were safe, with over 84% of patients experiencing no toxicity.

The study found that while the 30 Gy group had better local failure rates and overall survival compared to the 34 Gy group, the differences were not statistically significant, confirming the efficacy of SBRT for inoperable early-stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

30 Gy or 34 Gy? Comparing 2 single-fraction SBRT dose schedules for stage I medically inoperable non-small cell lung cancer. Videtic, GM., Stephans, KL., Woody, NM., 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 86 patients with Stage I non-small-cell lung cancer, stereotactic body radiotherapy (SBRT) was found to be significantly less expensive than conventional external beam radiation therapy (EBRT), costing $10,616 compared to $13,639 for EBRT.

SBRT demonstrated superior treatment outcomes, with a 36-month overall survival rate of 71% compared to 42% for EBRT, and a reduction in local failure rates by nearly three times (12% for SBRT vs. 34% for EBRT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy reduces treatment cost while improving overall survival and local control over standard fractionated radiation therapy for medically inoperable non-small-cell lung cancer. Lanni, TB., Grills, IS., Kestin, LL., et al.[2022]

In a study of 404 patients with medically inoperable non-small cell lung cancer, adding an endobronchial brachytherapy boost to external beam radiation therapy (EBRT) significantly improved local disease control rates from 32% to 58% at 5 years.

The benefit of brachytherapy was particularly notable in patients with smaller tumors (T(1-2) or ≤5.0 cm), and optimal local control was achieved when EBRT doses were ≥6500 cGy, with no increase in toxicity observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial brachytherapy and optimization of local disease control in medically inoperable non-small cell lung carcinoma: a matched-pair analysis. Mantz, CA., Dosoretz, DE., Rubenstein, JH., et al.[2018]

Stereotactic body radiotherapy (SBRT) has been shown to be a safe and effective treatment option for patients with early-stage lung cancer who are not candidates for surgery, demonstrating excellent local control and minimal acute toxicity.

Compared to traditional fractionated radiotherapy, SBRT may offer improved overall survival rates, and ongoing trials are investigating its potential use in operable patients as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of stereotactic body radiotherapy in the management of non-small cell lung cancer: an emerging standard for the medically inoperable patient? Videtic, GM., Stephans, KL.[2022]

In a study of 102 patients treated with stereotactic ablative radiation therapy (SABR) for early-stage non-small-cell lung cancer, a significant correlation was found between higher Biological Equivalent Doses (BED) over 300 Gy and the development of radiological changes such as organizing pneumonia and lung affectation over a 2-year follow-up.

Radiological changes were more pronounced in patients receiving BEDs greater than 300 Gy to healthy lung volumes of at least 30 cc, suggesting that these findings could inform future radiotherapy dose constraints to minimize pulmonary toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. Cases, C., Benegas, M., Sánchez, M., et al.[2023]

Stereotactic body radiotherapy (SBRT) is effective for treating early-stage non-small cell lung cancer (NSCLC) in patients who cannot undergo surgery, showing good outcomes and low toxicity for tumors located in the periphery.

However, the risk of severe toxicity increases for tumors near critical structures like the bronchial tree or mediastinum, highlighting the importance of careful dose-fractionation planning in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. Zarębska, I., Harat, M.[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 randomized phase 2 trial involving 98 medically inoperable patients with early-stage non-small cell lung cancer, a single fraction of 30 Gy was found to be as effective as 60 Gy delivered in three fractions regarding toxicity and cancer control outcomes.

Patients receiving the single fraction treatment reported better social functioning and less dyspnea at the 6-month follow-up, suggesting that 30 Gy in 1 fraction may improve quality of life compared to the 60 Gy in 3 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial. Singh, AK., Gomez-Suescun, JA., Stephans, KL., et al.[2021]

Stereotactic ablative radiation therapy (SABR) is now a standard treatment for stage I-II lung cancer patients who cannot undergo surgery, highlighting its efficacy in early-stage disease.

Intensity modulated radiation therapy (IMRT) allows for higher doses of radiation to be delivered safely while protecting surrounding healthy organs, and there is ongoing research into using SABR for stage IV lung cancer in combination with immunotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment: Radiation Therapy. Sampath, S.[2022]

Stereotactic ablative radiation therapy (SABR) is emerging as a viable alternative to surgical resection for treating early stage non-small cell lung cancer, especially as the incidence of this disease increases due to new lung screening guidelines.

Recent advancements in imaging and treatment planning have significantly improved the effectiveness and accuracy of SABR, making it a promising option for patients with early stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Stage I Lung Cancer with Stereotactic Ablative Radiation Therapy. Dan, T., Williams, NL.[2018]

References

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

30 Gy or 34 Gy? Comparing 2 single-fraction SBRT dose schedules for stage I medically inoperable non-small cell lung cancer. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Stereotactic radiotherapy reduces treatment cost while improving overall survival and local control over standard fractionated radiation therapy for medically inoperable non-small-cell lung cancer. [2022]

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

Endobronchial brachytherapy and optimization of local disease control in medically inoperable non-small cell lung carcinoma: a matched-pair analysis. [2018]

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

The role of stereotactic body radiotherapy in the management of non-small cell lung cancer: an emerging standard for the medically inoperable patient? [2022]

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

Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. [2023]

7. Singapore pubmed.ncbi.nlm.nih.gov

An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. [2023]

8. 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]

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

One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial. [2021]

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

Treatment: Radiation Therapy. [2022]

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

Management of Stage I Lung Cancer with Stereotactic Ablative Radiation Therapy. [2018]