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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
Previous conventional RT to mediastinum/lung allowed as long as SBRT is not expected to have a high probability of impairing lung function
Eligible patients must have staging studies identifying them as: patients with stage I or II, non-metastatic NSCLC; patients with a non-lung primary that is controlled and which has metastasized to the lungs alone; the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from high-dose SBRT treatment to the primary or metastatic lung tumor
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 below
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I've had radiation to chest but it won't harm my lungs to have more.
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My lung cancer is in stage I or II, or I have cancer that has only spread to my lungs and is under control.
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My lungs are strong enough for targeted radiation therapy.
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My lung condition could be operated on, but doctors advise against surgery.
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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 cancer was confirmed by tests, or it's too risky to biopsy but shows growth on scans.
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My early stage lung cancer has not spread to nearby lymph nodes.

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%
Constipation
67%
Nausea
67%
Cough
67%
Hypotension
33%
Hyperchloraemia
33%
Seizure
33%
Pyrexia
33%
Vomiting
33%
Rectal haemorrhage
33%
Abdominal pain
33%
Haemorrhoids
33%
Proctitis
33%
Decreased appetite
33%
Hypokalaemia
33%
Fatigue
33%
Pain
33%
Hyperglycaemia
33%
Pain in extremity
33%
Dyspnoea
33%
Vision blurred
33%
Mood altered
33%
Sepsis
33%
Traumatic haematoma
33%
Micturition urgency
33%
Nocturia
33%
Pollakiuria
33%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 Dose Level 1
Phase 1 Dose Level 2
Phase 1 Dose Level 3
Phase 2 Cohort 2a
Phase 2 Cohort 2b
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
118 Previous Clinical Trials
38,483 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,463 Previous Clinical Trials
483,334 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
~5 spots leftby Sep 2024