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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 10 years
Awards & highlights

Summary

This trial looks at a new way to treat lung tumours using high doses of radiation over a shorter period of time. It will study how safe and effective it is.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine local control in patients treated with SBRT.
Determine pattern of relapse in patients treated with SBRT.
Determine survival rates in patients treated with SBRT.
Secondary outcome measures
Assess the use of 4D-computed tomography (CT) planning to determine Internal Treatment Volume (ITV) and Planning Treatment Volume (PTV)
Assess the use of Cone Beam CT for precision imaging of the target and avoidance structures at each treatment
Assess the use of PET/CT in aiding target definition and predicting local response
+5 more

Side effects data

From 2019 Phase 1 & 2 trial • 160 Patients • NCT02052648
67%
Hypotension
67%
Nausea
67%
Cough
67%
Constipation
33%
Seizure
33%
Sepsis
33%
Haemorrhoids
33%
Hyperchloraemia
33%
Mood altered
33%
Pollakiuria
33%
Pain
33%
Rectal haemorrhage
33%
Hypokalaemia
33%
Nocturia
33%
Traumatic haematoma
33%
Micturition urgency
33%
Proctitis
33%
Pain in extremity
33%
Fatigue
33%
Abdominal pain
33%
Dyspnoea
33%
Vision blurred
33%
Urinary incontinence
33%
Vomiting
33%
Hyperglycaemia
33%
Decreased appetite
33%
Pyrexia
100%
80%
60%
40%
20%
0%
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

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

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.

Find a Location

Who is running the clinical trial?

Princess Margaret Hospital, CanadaOTHER
119 Previous Clinical Trials
38,859 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,492 Previous Clinical Trials
489,844 Total Patients Enrolled
John Cho, MDPrincipal InvestigatorUniversity Health Network, Princess Margaret Hospital
5 Previous Clinical Trials
245 Total Patients Enrolled
~1 spots leftby Sep 2024