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New radiation approach aims to safely treat Hard-to-Reach lung tumors

NCT ID NCT03306680

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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).

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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

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