Stereotactic Radiotherapy for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by John Cho, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University Health Network, Toronto

Must not be taking: Chemotherapy, Immunotherapy, Biological therapy

Disqualifiers: Active infection, Auto-immune diseases, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing SBRT, a precise radiation treatment for lung tumors. It targets tumors with high doses from multiple angles to shrink them and control cancer growth. The treatment is aimed at patients with lung cancer and metastases. SBRT, also known as stereotactic ablative radiotherapy (SABR), is a precise radiation treatment developed originally for intracranial targets and now widely used for treating lung tumors and metastases.

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 data supports the effectiveness of the treatment Stereotactic Radiation for lung cancer?

Stereotactic radiotherapy is shown to be effective for early-stage non-small-cell lung cancer, achieving high local control rates of over 88% and being well-tolerated with fewer side effects. It is considered a standard treatment option, especially for patients who cannot undergo surgery, and is preferred over conventional radiotherapy in some countries due to its superior outcomes and convenience. ^{1 2 3 4 5}

Is stereotactic radiotherapy safe for lung cancer patients?

Stereotactic radiotherapy, also known as stereotactic body radiation therapy (SBRT), is generally considered safe for treating early-stage lung cancer, but it can have side effects. Some studies have noted risks like radiation pneumonitis (lung inflammation) and other adverse events, especially when treating tumors in ultra-central locations in the lungs. ^{6 7 8 9 10}

How is stereotactic radiotherapy different from other treatments for lung cancer?

Stereotactic radiotherapy for lung cancer is unique because it delivers high doses of radiation precisely to the tumor while minimizing damage to surrounding healthy tissue. This technique allows for fewer treatment sessions and is particularly effective for early-stage non-small-cell lung cancer and certain lung metastases, offering high local control rates with fewer complications. ^{5 11 12 13 14}

Research Team

John Cho, MD

Principal Investigator

University Health Network, Princess Margaret Hospital

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Stereotactic Radiation (Radiation Therapy)

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.

Participant Groups

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+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Dr. Kevin Smith

Princess Margaret Hospital, Canada

Chief Executive Officer since 2018

MD from University of Toronto

Dr. Andrea Bezjak

Princess Margaret Hospital, Canada

Chief Medical Officer

MD from University of Toronto

Findings from Research

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]

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]

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 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 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]

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]

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 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]

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 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 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]

References

1. United States 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. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Assessment of the response following stereotactic irradiation of lung primary tumors and metastases]. [2016]

3. France pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy for stage I lung cancer: current results and new developments. [2022]

4. United States 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. [2013]

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

[Stereotactic irradiation of lung tumors]. [2018]

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

Early pulmonary toxicity following lung stereotactic body radiation therapy delivered in consecutive daily fractions. [2022]

7. Ireland 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. [2023]

8. United States 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. [2020]

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

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. [2022]

11. France pubmed.ncbi.nlm.nih.gov

[Stereotactic ablative irradiation for lung cancer]. [2014]

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

Non-surgical treatment of lung cancer: personalised stereotactic ablative radiotherapy. [2016]

13. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for early-stage non-small-cell lung cancer. [2009]

14. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy (SBRT) for Stage I lung cancer. [2018]