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SUNSET: SBRT for Ultra-central NSCLC- a Safety and Efficacy Trial

NCT03306680 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-18

No results posted yet for this study

Summary

This multi-centre phase I dose-escalation study will use a time-to-event continual reassessment method (TIT-CRM).

Accrual will start at level 1 (60 Gy in 8 fractions). Patients will be assigned to treatment doses using the TITE-CRM model. The model will use all available information from previously accrued patients to assign the highest dose with a predicted risk of grade 3 toxicity of 30% or less.

Conditions

  • Non Small Cell Lung Cancer

Interventions

RADIATION

SBRT

Patients will be assigned to treatment doses using the TITE-CRM model.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Meredith Giuliani, MBBS, FRCPC · Princess Margaret Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2021-04-19
Completion
2026-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03306680 on ClinicalTrials.gov