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

September 12, 2025 updated by: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will use a time-to-event continual reassessment method (TITE-CRM). The study design is based on RTOG 0813 (described above), but with a more cautious approach, since the patients herein may constitute a high-risk subset of the patients enrolled in RTOG 0813. The modifications include a starting dose (60 Gy in 8 fractions) herein that is lower than the safe dose for central tumors as determined by RTOG 0813 (60 Gy in 5 fractions), and longer follow-up period during which patients are considered at-risk for toxicity, (i.e. two years herein vs. one year in RTOG 0813).

The primary endpoint of this study is the maximally tolerated dose (MTD) of radiotherapy for ultracentral tumors. The MTD is the dose of radiotherapy associated with a <30% rate of grade 3-5 toxicity occurring within 2 years of treatment.

Local Progression, Regional nodal progression, Distant metastases, Progression-Free Survival, Overall survival, patient reported outcomes and quality of life.

The correlative objectives of this study are to determine the prognostic value of ctDNA levels measured pre-treatment, at the end of treatment and 3- and 12-months after treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V8R 6V5
        • BC Cancer -Vancouver Island
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre
      • Toronto, Ontario, Canada, M5G 1X6
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre-Cedars Cancer Centre
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7S 0B1
        • Saskatoon Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.

  2. Stage T1-3, N0, M0 (UICC/AJCC Staging, 8th Ed.), tumor size < 6 cm, prior to registration, based upon the following minimum diagnostic workup:

    1. History/physical examination within 4 weeks prior to registration
    2. 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.
    3. 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.
    4. 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.
  3. ECOG performance status 0-2;
  4. age >18;
  5. 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.

Exclusion Criteria:

  1. 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.
  2. Any prior thoracic radiotherapy.
  3. Any prior chemotherapy for the study cancer (cancer proposed to be treated on the study).
  4. Prior surgery for the study cancer.
  5. Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression;
  6. Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression.
  7. Pregnancy.
  8. The following autoimmune and connective tissue diseases will be excluded: Scleroderma and Systemic lupus erythematosus
  9. patients with interstitial lung disease (ILD).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with ultra-central NSCLC T1-3 (<6cm) N0 M0

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximally tolerated dose (MTD)
Time Frame: Occurring within 2 years of treatment
MTD of radiotherapy for ultracentral tumors. The MTD is the dose of radiotherapy associated with a <30% rate of grade 3-5 toxicity occurring within 2 years of treatment.
Occurring within 2 years of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Local Progression
Time Frame: 3-5 years
3-5 years
Regional nodal progression
Time Frame: 3-5 years
Defined as presence of enlarged lymph nodes >1 cm [short axis] in the hilum or mediastinum.
3-5 years
Time to distant metastases
Time Frame: 3-5 years
3-5 years
Progression-Free Survival
Time Frame: 3-5 years
3-5 years
Overall survival
Time Frame: 3-5 years
3-5 years
Patient reported outcome
Time Frame: Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months
FACT-L
Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months
Quality of Life
Time Frame: Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months
EQ-5D-5L
Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meredith Giuliani, MBBS, FRCPC, Princess Margaret Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SUNSET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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