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Stereotactic Body Radiotherapy (SBRT) for Non-Small Cell Lung Cancer (LUSTRE Trial)

Phase 3
Waitlist Available
Led By Anand Swaminath
Research Sponsored by Ontario Clinical Oncology Group (OCOG)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

LUSTRE Trial Summary

This trial is testing whether a new type of radiation therapy, called stereotactic body radiotherapy (SBRT), is better than the standard radiation therapy (CRT) for treating early stage non-small cell lung cancer (NSCLC). The primary outcome is local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.

Eligible Conditions
  • Non-Small Cell Lung Cancer

LUSTRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Local Control
Secondary outcome measures
Cost-Utility
Disease
Event-Free Survival
+5 more

Side effects data

From 2022 Phase 3 trial • 27 Patients • NCT01926197
100%
Fatigue
100%
Aspartate aminotransferase increased
92%
Diarrhea
92%
Platelet count decreased
83%
Anemia
83%
Weight loss
83%
Alkaline phosphatase increased
83%
Nausea
75%
Pain, abdominal
67%
Decreased appetite (anorexia)
67%
Hypertension
58%
Hyperglycemia
58%
Nerve damage or injury (neuropathy)
58%
Hypokalemia
50%
Alanine aminotransferase increased
50%
White blood cell decreased
50%
Hypoalbuminemia
42%
White blood cell (WBC) count elevated (leukocytosis)
42%
Lymphocyte count decreased
33%
Bloating
33%
Edema, peripheral
25%
Vomiting
25%
Bad taste in mouth (dysgeusia)
25%
Hyponatremia
25%
Anxiety
25%
Pain
25%
Constipation
25%
Hypocalcemia
25%
Labored breathing (dyspnea)
17%
Muscle pain (myalgia)
17%
Indigestion (dyspepsia)
17%
Pain, back
17%
Flatulence
17%
General feeling of discomfort (malaise)
17%
Depression
17%
Hair loss, immune-realted (alopecia)
17%
Neutrophil count decreased
17%
Difficulty sleeping (insomnia)
17%
Oral inflammation (mucositis)
8%
Pain, flank
8%
Other, Creatinine decreased
8%
Lymphedema
8%
Hearing impaired
8%
Bleed (hemorrhage), gastrointestinal
8%
Edema, localized
8%
Thromboembolic event
8%
Allergic reaction
8%
Chills
8%
Fever
8%
Drowsiness, unusual (somnolence)
8%
Tiredness (fatigue)
8%
Muscle weakness lower limb
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Pain, stomach
8%
Pain, chest, non-cardiac
8%
Lymphocyte count increased
8%
Other, Neutrophil count increase
8%
Other, Protein total decrease
8%
Thrombocytopenia
8%
Weight gain
8%
Hypercalcemia
8%
Hypernatremia
8%
Dizziness
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tremor
8%
Rash
8%
Gastroparesis
8%
Flu-like symptoms
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Dehydration
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Confusion
8%
Other, axilla boil
8%
Other, hemoglobin decreased
8%
Infusion-related reaction
8%
Arthritis
8%
Generalized muscle weakness
8%
Memory impairment
8%
Movements involuntary
8%
Chronic kidney disease
8%
Cataract
8%
Other, excess in the stool (steatorrhea)
8%
Other, stool discolored, clay color
8%
Gamma-glutamyl transferase (GGT) increased
8%
Hypoglycemia
8%
Urinary incontinence
8%
Urinary urgency
8%
Urine discoloration
8%
Excessive sweating (hyperhidrosis)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified FOLFIRINOX
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

LUSTRE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Body RadiotherapyExperimental Treatment1 Intervention
Stereotactic Body Radiotherapy (SBRT)
Group II: Conventional RadiotherapyActive Control1 Intervention
Conventional Radiotherapy (CRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

Ontario Clinical Oncology Group (OCOG)Lead Sponsor
62 Previous Clinical Trials
41,561 Total Patients Enrolled
Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,421 Total Patients Enrolled
Anand SwaminathPrincipal InvestigatorOntario Clinical Oncology Group (OCOG)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Thoracic OncologyJournal
The Nordic-hilus Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window
Rosenberg, Stephen A., Raymond Mak, Rupesh Kotecha, Bill W. Loo Jr., and Suresh Senan. 2021. “The Nordic-hilus Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window”. Journal of Thoracic Oncology. Elsevier BV. doi:10.1016/j.jtho.2021.06.030.
clinicaltrials.govStudy
Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients
2014. "Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01968941.
~30 spots leftby May 2025
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