Who is eligible for clinical trial NCT03306680?

Participants must meet the protocol's inclusion criteria for Non Small Cell Lung Cancer. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT03306680 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-09-12

SUNSET: SBRT for Ultra-central NSCLC- a Safety and Efficacy Trial (NCT03306680)

🔵 Active, Not Recruiting Phase1 📋 Clinical Research Protocol Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (10 items).

Location: BC Cancer -Vancouver Island — Vancouver, British Columbia

Age range: 18 Years

🧪 Interventions in This Study

SBRT (RADIATION)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Pathologically (histologically or cytologically) proven diagnosis of non-small cell lung cancer (NSCLC); if the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is serial growth on serial (\>=2) CT imaging and/or FDG avidity that is strongly suggestive of a primary NSCLC.
Stage T1-3, N0, M0 (UICC/AJCC Staging, 8th Ed.), tumor size \< 6 cm, prior to registration, based upon the following minimum diagnostic workup:
History/physical examination within 4 weeks prior to registration
CT scan with contrast (unless medically contraindicated) within 12 weeks of registration. The CT scan will include the entirety of both lungs, the mediastinum, liver and adrenal glands; the primary tumor dimensions will be measured on CT. Note: Patients with lesions that cannot be visualized by CT scan are not eligible for the study.
Whole body positron emission tomography (PET) scan within 12 weeks of registration, using FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions.
Mediastinal lymph node sampling by any technique is encouraged but not required. Patients with hilar or mediastinal lymph nodes \<1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \> 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but nondiagnostic uptake) may still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer.
ECOG performance status 0-2;
age \>18;
Ultra-central tumor location: tumours whose planning target volume (PTV) is expected to touch or overlaps the central bronchial tree, esophagus, pulmonary vein, or pulmonary artery as determined at the time of consultation.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (e.g. carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 2 years is permitted.
Any prior thoracic radiotherapy.
Any prior chemotherapy for the study cancer (cancer proposed to be treated on the study).
Prior surgery for the study cancer.
Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression;
Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression.
Pregnancy.
The following autoimmune and connective tissue diseases will be excluded: Scleroderma and Systemic lupus erythematosus
patients with interstitial lung disease (ILD).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

BC Cancer -Vancouver Island — Vancouver, British Columbia
London Regional Cancer Program — London, Ontario
Sunnybrook Odette Cancer Centre — Toronto, Ontario
Princess Margaret Cancer Centre — Toronto, Ontario
Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec
McGill University Health Centre-Cedars Cancer Centre — Montreal, Quebec
Saskatoon Cancer Centre — Saskatoon, Saskatchewan

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Non Small Cell Lung Cancer clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗