Stereotactic Radiotherapy for Lung Cancer

Overseen By John Cho, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must not be taking: Chemotherapy, Immunotherapy, Biological therapy

Disqualifiers: Active infection, Auto-immune diseases, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of radiation treatment called Stereotactic Body Radiation Therapy (SBRT) to evaluate its effectiveness for lung tumors and potential side effects. Typically, radiation therapy spans several weeks, but in this study, participants receive high doses in just 3 to 10 sessions over 1 to 2 weeks. The trial seeks individuals with early-stage lung cancer or certain other cancers that have spread to the lungs but remain limited. Participants should have lung tumors meeting specific criteria and cannot undergo surgery. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not allow concurrent systemic therapy like chemotherapy, immunotherapy, or biological therapy, except for hormone therapy. If you are on these treatments, you may need to stop them to participate.

What prior data suggests that this protocol is safe for lung cancer treatment?

Research shows that Stereotactic Body Radiation Therapy (SBRT) is generally safe for treating lung cancer. Studies indicate that SBRT can effectively control cancer, with most patients experiencing only mild side effects. For example, one study found that patients treated with SBRT had good outcomes and manageable side effects.

In another study involving 154 patients with hard-to-treat lung tumors, SBRT was well-tolerated. Real-world evidence also supports that SBRT is safe for most people, meaning it usually doesn't cause severe side effects. However, some studies suggest more research is needed to confirm these findings.

Overall, SBRT has been used for over ten years and has a strong safety record, especially for early-stage lung cancer. However, like any treatment, it may carry risks, so discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic Radiation is unique because it delivers high doses of radiation with pinpoint precision, directly targeting lung tumors while sparing the surrounding healthy tissue. Unlike traditional radiation therapy, which can take several weeks and affect a larger area, Stereotactic Body Radiation Therapy (SBRT) is typically completed in just a few sessions. Researchers are excited about this treatment because it offers the potential for greater efficacy with fewer side effects, making it a promising option for lung cancer patients.

What evidence suggests that Stereotactic Radiation is effective for lung cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT), which participants in this trial will receive, is a promising treatment for lung cancer. Studies have found that SBRT can effectively shrink tumors and help control cancer over the long term. For early-stage non-small cell lung cancer (NSCLC), SBRT has proven successful and serves as a good option, especially for patients unable to undergo surgery. It delivers high doses of radiation in fewer sessions, typically between 3 to 10, reducing time spent in treatment. Clinical results have demonstrated good local control (preventing cancer from spreading) and overall survival rates, with fewer side effects compared to traditional radiation therapy. This suggests that SBRT can be a safe and effective way to manage lung cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

John Cho, MD

Principal Investigator

University Health Network, Princess Margaret Hospital

Are You a Good Fit for This Trial?

This trial is for adults with certain types of lung cancer, including early-stage non-metastatic NSCLC or controlled cancers that have spread to the lungs. Candidates must have adequate lung function, confirmed malignancy (or strong evidence without biopsy), and be considered inoperable or not ideal for surgery. They should not be on systemic treatments except hormone therapy, have no active infections or autoimmune diseases, and cannot be candidates for chemo-radiation.

Inclusion Criteria

My lung cancer is in stage I or II, or I have cancer that has only spread to my lungs and is under control.

Women of childbearing potential and male participants must use an effective contraceptive method

My lungs are strong enough for targeted radiation therapy.

Exclusion Criteria

I am not on any cancer treatment except for hormone therapy.

Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics

I have an ongoing infection in my body, lungs, or around my heart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Radiation

Trial Overview The study tests Stereotactic Body Radiation Therapy (SBRT) effectiveness in treating lung tumors over 3-10 sessions within 1-2 weeks. SBRT delivers high radiation doses directly to tumors aiming to shrink them and control cancer growth. The trial also seeks to refine treatment techniques and standardize follow-up procedures.

How Is the Trial Designed?

Group I: SBRT Experimental Treatment 1 Intervention

High dose of radiation will be used to treat tumours.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Published Research Related to This Trial

Stereotactic body radiation therapy (SBRT) has become an important treatment option for early-stage non-small-cell lung cancer, showing significant advancements in its application over the past decade.

The article reviews various aspects of SBRT, including its radiobiologic principles, technical execution, and clinical outcomes, highlighting its growing role in oncologic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for early-stage non-small-cell lung cancer. Lo, SS., Fakiris, AJ., Papiez, L., et al.[2009]

Stereotactic body radiation therapy (SBRT) has evolved from stereotactic radiosurgery and is now widely used for treating lung cancer, demonstrating high local control rates.

Clinical studies indicate that SBRT has acceptable toxicity levels, making it a promising option for lung cancer treatment, with ongoing trials continuing to evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy (SBRT) for Stage I lung cancer. Nagata, Y., Kimura, T.[2018]

Stereotactic body radiation therapy (SBRT) demonstrated a 3-year overall survival rate of 59.9% for inoperable patients and 76.5% for operable patients with T1N0M0 non-small cell lung cancer, indicating its efficacy as a treatment option.

The treatment was associated with low rates of severe toxicities, with only 10 patients experiencing grade 3 and 2 patients experiencing grade 4 toxicities, suggesting that SBRT is a safe alternative to surgery for early-stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. Nagata, Y., Hiraoka, M., Shibata, T., et al.[2022]

In a study of 855 patients with early-stage non-small-cell lung cancer treated with stereotactic ablative radiotherapy, the 3-year and 5-year local control rates were high at 92.4% and 90.9%, respectively, indicating the treatment's efficacy in preventing local recurrences.

The study found that 16.7% of patients developed second primary lung cancers (SPLC) within 5 years, highlighting the need for long-term follow-up with CT scans to monitor for both local recurrences and SPLC in patients who are eligible for further radical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of Disease Recurrence after SABR for Early Stage Non-Small-Cell Lung Cancer: Optimizing Follow-Up Schedules for Salvage Therapy. Verstegen, NE., Lagerwaard, FJ., Hashemi, SM., et al.[2022]

The study analyzed data from nine observational studies to determine that specific dosimetric factors, such as V5 and V20, are significant risk factors for developing radiation pneumonitis (RP) after stereotactic body radiotherapy (SBRT) for lung tumors.

Key thresholds identified include a planning target volume (PTV) greater than 145 cm³ and a mean lung dose (MLD) of 4.7 Gy or more, indicating that careful assessment of lung dose volume histograms is crucial for predicting RP risk in patients undergoing SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating risk factors of radiation pneumonitis after stereotactic body radiation therapy in lung tumor: Meta-analysis of 9 observational studies. Lu, C., Lei, Z., Wu, H., et al.[2020]

Stereotactic radiotherapy (SRT) can achieve local control rates over 88% in early-stage non-small cell lung cancer (NSCLC) with minimal treatment-related toxicity when using risk-adapted fractionation schemes.

SRT is increasingly preferred over conventional radiotherapy due to its superior outcomes and convenience, especially for patients aged 75 and older who are at high risk for surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy for stage I lung cancer: current results and new developments. Senan, S., Lagerwaard, F.[2022]

The report analyzes a decade's worth of data from a large single-institution program, highlighting trends in the use of stereotactic lung radiotherapy, which is a precise form of radiation treatment for lung tumors.

It emphasizes changes in patient demographics, tumor types, and treatment protocols, indicating evolving practices in lung cancer management over the years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief report of 10-year trends in the use of stereotactic lung radiotherapy at a dutch academic medical center. Peguret, N., Dahele, M., Lagerwaard, F., et al.[2013]

Stereotactic radiotherapy for lung cancer is an effective treatment option, demonstrating very high local control rates and acceptable survival rates, especially when considering patient age and other health conditions.

Complications from this treatment are rare, making it a safe choice in the therapeutic management of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic ablative irradiation for lung cancer]. Antoni, D., Srour, I., Noël, G., et al.[2014]

Stereotactic irradiation allows for higher radiation doses to lung tumors while minimizing damage to surrounding healthy tissue, making it a promising technique for treating localized early-stage non-small-cell lung cancer.

Although based on small patient groups and limited long-term data, the results indicate that this method correlates with improved local tumor control and may also be effective for treating lung metastases from other solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic irradiation of lung tumors]. Hof, H., Herfarth, K., Debus, J.[2018]

In a study of 84 patients treated with stereotactic body radiation therapy (SBRT) for lung cancer, the incidence of early pulmonary toxicity (grade ≥ 2 pneumonitis) was relatively low at 12.5%, indicating that SBRT is generally well tolerated.

Among patients receiving higher doses (54Gy in 3 fractions), the incidence of pneumonitis was slightly higher at 14.3%, but overall, the treatment did not lead to excessive early pulmonary toxicity, suggesting its safety for both central and peripheral lung lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early pulmonary toxicity following lung stereotactic body radiation therapy delivered in consecutive daily fractions. Stauder, MC., Macdonald, OK., Olivier, KR., et al.[2022]

Stereotactic ablative radiotherapy is now a standard treatment for patients with medically inoperable stage I non-small-cell lung cancer and certain lung metastases, highlighting its efficacy in these cases.

The use of techniques to freeze or limit tumor movement, along with image-guided radiation delivery, is crucial for ensuring effective treatment while protecting surrounding healthy tissues from radiation overdose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-surgical treatment of lung cancer: personalised stereotactic ablative radiotherapy. Tsang, MW., Kam, MK., Leung, SF., et al.[2016]

Stereotactic body radiotherapy (SBRT) for ultra-central lung tumors shows high efficacy, with pooled local control rates of 92% at 1 year and 89% at 2 years, based on a systematic review of 27 studies involving 1183 treated targets.

While SBRT is effective, it carries risks of severe toxicity, with a 6% incidence of grade 3-4 toxicities and a 4% incidence of treatment-related deaths, highlighting the importance of careful patient selection and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for Ultra-Central lung Tumors: A systematic review and Meta-Analysis and International Stereotactic Radiosurgery Society practice guidelines. Yan, M., Louie, AV., Kotecha, R., et al.[2023]

Stereotactic radiotherapy is an effective treatment for patients with stage I non-small cell lung cancer who cannot undergo surgery, showing comparable overall survival rates to those who can have surgery.

This treatment is also well tolerated and has been successfully used for pulmonary oligometastases, highlighting the importance of early recurrence detection for patients who may still be eligible for curative surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessment of the response following stereotactic irradiation of lung primary tumors and metastases]. Barillot, I., Munier, O., Hatime, M., et al.[2016]

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]

Citations

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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.

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Stereotactic ablative radiotherapy for locally advanced non ... This meta-analysis presents promising findings regarding LC and OS rates, while also observing low toxicity rates, indicating the potential feasibility of SABR ...

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Stereotactic body radiotherapy in lung cancer The purpose of this study is to summarize the current developments, randomised studies, guidelines about lung SBRT, with emphasis on the possibility of ...

4. jto.org jto.org/article/S1556-0864(15)31728-7/fulltext

Outcomes of Stereotactic Ablative Radiotherapy for ... SABR was delivered in eight fractions of 7.5 Gy to 63 such patients between 2003 and 2009. Of these, 37 patients had a tumor at a central hilar location, ...

5. ccts.amegroups.org ccts.amegroups.org/article/view/52566/html

Advances in stereotactic body radiation therapy for early stage ... Stereotactic body radiation therapy (SBRT) has emerged as an effective, non-invasive treatment option for patients with medically inoperable NSCLC.

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Four-year follow-up outcomes after stereotactic body radiation ... SBRT with a BED 100 Gy in 4–10 fractions is effective and acceptable for treating patients with central early-stage NSCLC. Further studies are warranted.

7. redjournal.org redjournal.org/article/S0360-3016(24)00508-X/fulltext

Safety and Efficacy of Stereotactic Body Radiation Therapy ... A total of 154 patients received SBRT to 162 ultracentral lesions during our study period, with baseline characteristics described in Table 1.

8. jto.org jto.org/article/S1556-0864(24)00684-1/fulltext

Real-World Acute Toxicity and 90-Day Mortality in Patients ... This study aimed to uncover the real-world incidence of acute toxicity and 90-day mortality in patients with SBRT-treated stage I NSCLC and ...

9. ascopubs.org ascopubs.org/doi/10.1200/GO.22.00061

Real-World Evidence of Health Outcomes Related to Lung ... Our results indicate that SBRT is effective (high local control and acceptable toxicity) for treating malignant lung lesions in a real-world scenario in Latin ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850021003349

Clinical Outcomes and Safety Profile in the Treatment of ... Synchronous SBRT to biologically effective dose ≥100 Gy appears safe and effective for selected patients with synchronous primary lung tumors.