What side effects are associated with this type of intervention?

Stereotactic Body Radiation Therapy (SBRT) for Non-Small Cell Lung Cancer (NSCLC) is generally well-tolerated but can cause side effects such as fatigue, skin irritation, and inflammation of the lungs (radiation pneumonitis). Other common treatments for NSCLC include chemotherapy, which can lead to nausea, vomiting, hair loss, and increased risk of infection, and immunotherapy, which may cause immune-related side effects like colitis, dermatitis, and pneumonitis. Patients should discuss potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that involve high-precision, high-dose radiation therapy similar to Stereotactic Body Radiation Therapy (SBRT). SBRT is a form of radiation therapy that delivers high doses of radiation to a precise target, minimizing damage to surrounding healthy tissue. This method is particularly effective for treating small, well-defined tumors. Additionally, the FDA has approved various systemic therapies, including immunotherapies like pembrolizumab and nivolumab, and targeted therapies for specific genetic mutations in NSCLC. These treatments can be used in combination with radiation therapy to enhance overall treatment efficacy.

What other types of research exist?

Promising novel alternatives to SBRT for NSCLC patients include: 1) Proton Beam Therapy, which offers superior survival rates and reduced toxicity compared to standard radiation. 2) Targeted therapies such as Alectinib, Crizotinib, Entrectinib, Ceritinib, and Lorlatinib for patients with specific genetic mutations (e.g., ALK, ROS1). 3) Immunotherapy combinations like Atezolizumab plus Bevacizumab with chemotherapy, which have shown improved progression-free and overall survival in clinical trials. These alternatives provide personalized treatment options based on genetic profiles and specific patient needs.

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Radiation Therapy

Stereotactic Radiotherapy for Lung Cancer

Phase 2

Recruiting

Led By John Cho, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate lung function to tolerate the planned stereotactic radiation

In patients with early stage primary NSCLC and a co-existing malignancy, the co-existing malignancy must have an expected prognosis better than primary lung lesion

Must not have

No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed

Patients with active systemic, pulmonary or pericardial infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include damage to surrounding tissues leading to symptoms like coughing, shortness of breath, chest pain; fatigue; skin reactions at the treatment site; rarely more severe complications such as bleeding or pneumonia may occur due to high-dose exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lungs are strong enough for targeted radiation therapy.

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My other cancer is expected to have a better outcome than my lung cancer.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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My early stage lung cancer has not spread to nearby lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 1 & 2 trial • 160 Patients • NCT02052648

67%

Constipation

67%

Hypotension

67%

Cough

67%

Nausea

33%

Proctitis

33%

Seizure

33%

Haemorrhoids

33%

Hypokalaemia

33%

Pain in extremity

33%

Abdominal pain

33%

Urinary incontinence

33%

Vomiting

33%

Vision blurred

33%

Dyspnoea

33%

Pollakiuria

33%

Micturition urgency

33%

Decreased appetite

33%

Hyperglycaemia

33%

Traumatic haematoma

33%

Rectal haemorrhage

33%

Pyrexia

33%

Hyperchloraemia

33%

Fatigue

33%

Pain

33%

Mood altered

33%

Sepsis

33%

Nocturia

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1 Dose Level 1

Phase 2 Cohort 2b

Phase 2 Cohort 2a

Phase 1 Dose Level 2

Phase 1 Dose Level 3

Phase 2 Cohort 2c

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SBRTExperimental Treatment1 Intervention

High dose of radiation will be used to treat tumours.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiation

2014

Completed Phase 2

~170

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Stereotactic Body Radiation Therapy (SBRT) is a common treatment for Non-Small Cell Lung Cancer (NSCLC) that delivers high doses of radiation precisely targeted to tumors, effectively shrinking them and controlling cancer while minimizing damage to surrounding healthy tissues. This precision is crucial for NSCLC patients as it allows for effective tumor control with fewer side effects. Other common treatments include chemotherapy, which kills rapidly dividing cells; targeted therapy, which focuses on specific genetic mutations in cancer cells; and immunotherapy, which boosts the immune system to fight cancer. These treatments provide multiple strategies to manage NSCLC, improving patient outcomes and quality of life.

Stereotactic body radiotherapy treatment of extracranial metastases.