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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether side effects from radiation therapy vary based on the treatment schedule for individuals with early-stage lung cancer. Participants will receive either three or five sessions of radiation therapy, assigned randomly. The trial targets individuals diagnosed with specific types of non-small cell lung cancer who have undergone certain medical evaluations and show no cancer spread to other body parts. The research seeks to improve understanding of how different radiation schedules affect patients' experiences. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that stereotactic body radiation therapy (SBRT) has been tested in various ways for treating early-stage lung cancer. In one method, treatment is given in three sessions, and some studies found serious side effects. Specifically, more than half of the patients with certain tumor types experienced severe harm. Another study found that 8 out of 9 patients developed narrowed airways when treated with 3-4 daily sessions.

In the method with five sessions, significant side effects were also reported. Some studies noted that 15% of patients experienced very severe or life-threatening reactions. Despite these risks, SBRT remains a safe and effective treatment for those unable to undergo surgery.

Overall, both the three-session and five-session methods of SBRT can have serious side effects, but they are important options for patients with early-stage lung cancer who cannot have surgery. Discussing potential risks and benefits with a healthcare provider is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring different radiation schedules for early-stage lung cancer because these approaches aim to optimize treatment effectiveness and convenience for patients. Traditional radiation therapy often requires many sessions over several weeks. These new schedules involve either just 3 or 5 fractions of stereotactic body radiotherapy, potentially offering a shorter, more intense treatment plan. This could mean fewer hospital visits and a more targeted attack on cancer cells, which might translate to better outcomes with reduced side effects. By refining these schedules, researchers hope to improve patients' quality of life during treatment.

What evidence suggests that this trial's radiation schedules could be effective for early-stage lung cancer?

Research has shown that stereotactic body radiation therapy (SBRT) effectively treats early-stage non-small cell lung cancer (NSCLC). In this trial, participants will receive either SBRT in three sessions or SBRT in five sessions. Studies have found that SBRT in three sessions provides excellent cancer control with few side effects, making it suitable for patients who cannot undergo surgery. Similarly, SBRT in five sessions has offered survival rates comparable to other treatment schedules for both central and outer lung tumors. Patients have tolerated both the three-session and five-session treatments well, with similar outcomes. Overall, SBRT appears to be a safe and effective alternative to surgery for early-stage lung cancer. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6961954/

and Three-Fraction Schedules of Stereotactic Body Radiation ... We compared the clinical outcome of single- and three-fraction stereotactic body radiation therapy schedules for early-stage non-small cell lung cancer (n=159).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6318482/

Stereotactic body radiation therapy for non-small cell lung ... This literature review provides an updated analysis of prospective clinical trials evaluating clinical outcomes following SBRT for early stage NSCLC.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1879850024002753

Stereotactic Body Radiation Therapy for Primary Lung ... This case-based discussion provides a practical framework for delivering SBRT to challenging, yet frequently encountered, cases in radiation oncology.

4. ascopubs.org ascopubs.org/doi/10.1200/OP.22.00475

Stereotactic Body Radiotherapy for the Management of ... Having been shown to be safe, effective, and favorable for a vulnerable patient population, SBRT has revolutionized the treatment of early-stage NSCLC.

5. jtd.amegroups.org jtd.amegroups.org/article/view/21383/html

Stereotactic body radiation therapy (SBRT) for early stage ... SBRT has evolved as a viable alternative to surgery for medically inoperable patients, achieving excellent local control (LC) with relatively minimal toxicity.

6. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/185547

Stereotactic Body Radiation Therapy for Inoperable Early ... Patients with inoperable non–small cell lung cancer who received stereotactic body radiation therapy had a survival rate of 55.8% at 3 years.