SBRT for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byMeredith Giuliani, MBBS, FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests different levels of radiation to find the safest high dose for patients with high-risk ultracentral tumors. It uses a method that adjusts doses based on patient responses to minimize severe side effects.

Eligibility Criteria

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.

Inclusion Criteria

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.

- History/physical examination within 4 weeks prior to registration

+6 more

Exclusion Criteria

I plan to undergo other local treatments while participating in this study, except if my disease worsens.

I plan to undergo systemic therapy while participating in this study.

I have had radiation therapy to the chest area before.

+6 more

Participant Groups

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.

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

SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as SBRT for: