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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
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 moreSide effects data
From 2019 Phase 1 & 2 trial • 160 Patients • NCT0205264867%
Hypotension
67%
Nausea
67%
Constipation
67%
Cough
33%
Vision blurred
33%
Seizure
33%
Fatigue
33%
Traumatic haematoma
33%
Mood altered
33%
Dyspnoea
33%
Abdominal pain
33%
Haemorrhoids
33%
Urinary incontinence
33%
Pain in extremity
33%
Hyperchloraemia
33%
Micturition urgency
33%
Pollakiuria
33%
Nocturia
33%
Pain
33%
Rectal haemorrhage
33%
Hypokalaemia
33%
Proctitis
33%
Sepsis
33%
Decreased appetite
33%
Vomiting
33%
Hyperglycaemia
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
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
1,481 Previous Clinical Trials
486,201 Total Patients Enrolled
John Cho, MDPrincipal InvestigatorUniversity Health Network, Princess Margaret Hospital
5 Previous Clinical Trials
245 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals being enrolled in the study currently?
"Affirmative. According to the information posted on clinicaltrials.gov, this research project is still enrolling patients as of October 21st 2022; it was initially published on March 1 2006 and requires 200 participants from a single medical centre."
Answered by AI
Has the FDA sanctioned Stereotactic Radiation as a viable therapy?
"We predict that stereotactic radiation's safety is a 2 on the scale of 1 to 3 because clinical trials have revealed reassuring data, but efficacy has yet been confirmed."
Answered by AI
How many participants are being observed in the current research project?
"Affirmative. Accurate information is available on clinicaltrials.gov and shows this medical trial was initially posted in March of 2006, with the latest update made on October 21st 2022. This study aims to recruit 200 individuals from a single location."
Answered by AI
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