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

NCT03306680 | Active Not Recruiting Phase 1

• 1 other identifier: SUNSET
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Maximally tolerated dose (MTD)

  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 Outcomes (7)

• Time to Local Progression

  3-5 years

• Regional nodal progression

  3-5 years

• Time to distant metastases

  3-5 years

• Progression-Free Survival

  3-5 years

• Overall survival

  3-5 years

Study Arms (1)

Patients with ultra-central NSCLC T1-3 (<6cm) N0 M0

EXPERIMENTAL

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

Interventions

SBRT RADIATION

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

Patients with ultra-central NSCLC T1-3 (<6cm) N0 M0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (7)

BC Cancer -Vancouver Island

Vancouver, British Columbia, V8R 6V5, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1X6, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

McGill University Health Centre-Cedars Cancer Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7S 0B1, Canada

Location

Related Publications (1)

• Rosenberg SA, Mak R, Kotecha R, Loo BW Jr, Senan S. The Nordic-HILUS Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window. J Thorac Oncol. 2021 Oct;16(10):e79-e80. doi: 10.1016/j.jtho.2021.06.030. No abstract available.

  PMID: 34561039 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Meredith Giuliani, MBBS, FRCPC

  Princess Margaret Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 11, 2017
• Study Start: January 19, 2018
• Primary Completion: April 19, 2021
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)