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Radiation Therapy
SBRT for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Led By Meredith Giuliani, MBBS, FRCPC
Research Sponsored by Lawson Health Research Institute
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 3-5 years
Awards & highlights
Study Summary
This trial will use a time-to-event continual reassessment method (TIT-CRM) to study the safety of escalating doses of radiation therapy.
Who is the study for?
This trial is for adults over 18 with a confirmed or strongly suspected diagnosis of non-small cell lung cancer (NSCLC) that hasn't spread beyond the lungs and is less than 6 cm in size. It's specifically for those whose tumors are very close to central structures like main airways or blood vessels. Participants should be relatively fit (ECOG status 0-2), and not have had prior chemotherapy, thoracic radiotherapy, or surgery for their lung cancer.Check my eligibility
What is being tested?
The SUNSET trial tests different doses of Stereotactic Body Radiation Therapy (SBRT) to find the highest safe dose with acceptable side effects for treating ultra-central NSCLC. The study uses an advanced method called TITE-CRM that adjusts treatment based on how earlier patients responded.See study design
What are the potential side effects?
Potential side effects from SBRT may include fatigue, skin reactions at the treatment site, difficulty swallowing if the esophagus is affected, shortness of breath if lung tissue is irritated, and other organ-specific issues depending on where radiation overlaps with nearby structures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximally tolerated dose (MTD)
Secondary outcome measures
Overall survival
Patient reported outcome
Progression-Free Survival
+4 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with ultra-central NSCLC T1-3 (<6cm) N0 M0Experimental Treatment1 Intervention
Level-1 Dose per fraction: 4Gy Number of fractions: 15 Total Dose: 60 Gy
Level 0 Dose per fraction: 6Gy Number of fractions: 10 Total Dose: 60 Gy
Level 1 Dose per fraction: 7.5 Gy Number of fractions: 8 Total Dose: 60 Gy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
656 Previous Clinical Trials
413,398 Total Patients Enrolled
Meredith Giuliani, MBBS, FRCPCPrincipal InvestigatorPrincess Margaret Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to undergo other local treatments while participating in this study, except if my disease worsens.I am able to get out of my bed or chair and move around.My cancer is in an early stage, has not spread to lymph nodes or other parts of the body, and the tumor is smaller than 6 cm.I plan to undergo systemic therapy while participating in this study.My lung cancer diagnosis is confirmed or strongly indicated by CT scans and tests.My tests show no signs of cancer in my chest lymph nodes or all biopsies are negative.I've had a PET scan within the last 3 months that clearly shows my primary tumor and nearby lymph nodes.I have had radiation therapy to the chest area before.I have had surgery for my cancer.I have been cancer-free for at least 2 years, except for non-dangerous skin cancers.I do not have scleroderma or systemic lupus erythematosus.I've had a CT scan with contrast covering required areas within the last 12 weeks.My tumor is very close to or touching major parts of my lung or esophagus.I am older than 18 years.I have not received chemotherapy for my current cancer.I have interstitial lung disease.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with ultra-central NSCLC T1-3 (<6cm) N0 M0
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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