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ACTIVE NOT RECRUITING
NCT03306680
PHASE1

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

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2018-01-19

Completion Date

2026-09

Last Updated

2025-09-18

Healthy Volunteers

No

Interventions

RADIATION

SBRT

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

Locations (7)

BC Cancer -Vancouver Island

Vancouver, British Columbia, Canada

London Regional Cancer Program

London, Ontario, Canada

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

McGill University Health Centre-Cedars Cancer Centre

Montreal, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada