New radiation approach aims to safely treat Hard-to-Reach lung tumors
NCT ID NCT03306680
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 1 trial tests a precise, high-dose radiation technique called SBRT for patients with non-small cell lung cancer whose tumors are located in the ultra-central part of the chest, near the windpipe and major blood vessels. The study enrolls 30 participants to find the highest safe dose that keeps the risk of serious side effects under 30% within two years. Researchers will also track cancer progression, survival, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (SBRT)
- What this could lead to
- If successful, this could establish a safer radiation dose for hard-to-treat lung tumors located near the center of the chest.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply broadly. The main risk is serious side effects from radiation hitting nearby vital structures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2018
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
BC Cancer -Vancouver Island
Vancouver, British Columbia, V8R 6V5, Canada
-
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9, Canada
-
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
-
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, H4A 3J1, Canada
-
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1X6, Canada
-
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7S 0B1, Canada
-
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer