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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

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 weeks
Treatment ~ Varies
Follow Up ~3-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 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
Maximally tolerated dose (MTD)
Secondary outcome measures
Overall survival
Patient reported outcome
Progression-Free Survival
+4 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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

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
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, immunotherapy, and radiation therapy. Chemotherapy works by damaging the DNA of rapidly dividing cells, leading to cell death. Targeted therapy inhibits specific molecular pathways essential for cancer cell growth and survival, such as EGFR or ALK mutations. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Radiation therapy delivers high-energy particles or waves to destroy or damage cancer cells, which is particularly important for shrinking tumors, alleviating symptoms, and improving survival rates in NSCLC patients.

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
666 Previous Clinical Trials
414,236 Total Patients Enrolled
Meredith Giuliani, MBBS, FRCPCPrincipal InvestigatorPrincess Margaret Cancer Center

Media Library

SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03306680 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Patients with ultra-central NSCLC T1-3 (<6cm) N0 M0
Non-Small Cell Lung Cancer Clinical Trial 2023: SBRT Highlights & Side Effects. Trial Name: NCT03306680 — Phase 1
SBRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03306680 — Phase 1
~4 spots leftby Jul 2025