Active not recruitingPHASE1INTERVENTIONAL

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

This study, called SUNSET, is investigating a specific type of radiation treatment, Stereotactic Body Radiation Therapy (SBRT), for a form of lung cancer known as Non-Small Cell Lung Cancer. This cancer is located very close to important organs like your windpipe or major blood vessels. We aim to find the best dose of this radiation that is both effective at treating the cancer and causes the fewest serious side effects. Researchers will start with a lower dose and gradually increase it, closely watching how patients respond over a two-year period. This research is important because it could help doctors treat these difficult-to-reach tumours more safely and effectively in the future, improving patient outcomes.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

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

Enrolment target

Start

19 Jan 2018

Estimated completion

01 Sep 2026

Non Small Cell Lung Cancer

What is this study about?

This study, called SUNSET, is about finding the best and safest way to use a special type of radiation treatment called SBRT (Stereotactic Body Radiation Therapy) for a common type of lung cancer known as Non-Small Cell Lung Cancer. This particular study focuses on tumours located in a very sensitive area: right next to important organs like your windpipe, swallowing tube (oesophagus), or major blood vessels in the chest. Because these tumours are so close to vital organs, treating them needs a very careful approach to avoid harm.

The main goal of this study is to work out the highest dose of SBRT that can be given safely without causing serious side effects, while still being effective against the cancer. To do this, we'll start with a lower radiation dose and, if it proves safe, cautiously increase it for other patients. Doctors will carefully monitor everyone for any side effects for two years after treatment. This step-by-step approach helps ensure patient safety throughout the trial.

Ultimately, this research aims to improve how we treat Non-Small Cell Lung Cancer in these tricky, central locations. By finding the safest and most effective radiation dose, we hope to offer better treatment options for patients in the future. We will also be looking at other important aspects like how the cancer responds, how long patients live, and how their quality of life is affected, including checking for tiny bits of cancer DNA in the blood.

Key takeaways

This study focuses on a specific radiation treatment (SBRT) for lung cancer near vital organs.
The main goal is to find the safest yet most effective radiation dose for these challenging tumours.
Patients will be closely monitored for two years after treatment for side effects and how the cancer responds.
Eligible participants have early-stage Non-Small Cell Lung Cancer in an 'ultra-central' location.
The study aims to improve future treatment options for this type of lung cancer.

Who may be eligible?

To be considered for this study, you need to have a confirmed diagnosis of Non-Small Cell Lung Cancer, or strong evidence pointing to it if a biopsy is too risky. Your cancer should be in an early stage (T1-3, N0, M0) and smaller than 6 cm. Importantly, the tumour must be located very close to or touching vital structures in your chest, such as the main airways, oesophagus, or major blood vessels. You also need to be at least 18 years old and generally well enough to participate, as assessed by doctors.

There are also some reasons why you might not be able to join. For example, if you've had other serious cancers in the past two years (excluding certain skin cancers), you usually won't be eligible. The medical team will review all your health information and scans to make sure this study is right for you and that you meet all necessary criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have Non-Small Cell Lung Cancer?
Is my tumour located very close to my windpipe, oesophagus, or main blood vessels?
Is my cancer in an early stage and smaller than 6 cm?
Am I at least 18 years old?
Am I generally well enough to participate, as determined by my doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a specific type of radiation treatment called SBRT. The exact dose will be carefully chosen by the study doctors. Before treatment, you'll have several scans, such as CT and PET scans, and a physical exam to understand your cancer and overall health. During the treatment, you will attend a number of hospital visits to receive your radiation doses, typically spread over a few appointments.

After your treatment is complete, you will have regular follow-up appointments and scans over the next two years. These visits are very important for the doctors to monitor how well the treatment is working, check for any side effects, and assess your overall recovery and quality of life. You may also have blood tests to look for specific cancer markers. The total duration of active follow-up for monitoring purposes will be two years.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is receiving a targeted radiation treatment (SBRT) for your lung cancer that is carefully designed to be as effective as possible while trying to reduce serious side effects. You will also receive very close monitoring of your health and cancer. However, as with any medical treatment, there are potential risks, including side effects from the radiation, which could range from mild to severe, though the study is designed to explore the safest effective dose. Potential side effects could include issues with your lungs, oesophagus, or blood vessels, given the tumour's location. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

BC Cancer -Vancouver Island
Verified postcode
Vancouver, Canada
London Regional Cancer Program
Verified postcode
London, Canada
Sunnybrook Odette Cancer Centre
Verified postcode
Toronto, Canada
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Verified postcode
Montreal, Canada
McGill University Health Centre-Cedars Cancer Centre
Verified postcode
Montreal, Canada
Saskatoon Cancer Centre
Verified postcode
Saskatoon, Canada

Common questions

What is SBRT?

SBRT is a highly precise type of radiation therapy that delivers high doses of radiation to a tumour while minimising harm to surrounding healthy tissues. It's often given in fewer sessions compared to standard radiation.

What does 'ultra-central' mean for my tumour?

An 'ultra-central' tumour means it's located very close to vital organs in your chest, such as your windpipe, food pipe (oesophagus), or major blood vessels like the pulmonary artery or vein.

Will I know what dose of radiation I'm getting?

Yes, your medical team will explain the specific radiation dose you will receive and why it was chosen based on the study's safety plan.

How long will I be followed up after treatment?

You'll be closely monitored for two years after your treatment ends, with regular check-ups and scans to ensure your well-being and assess the treatment's effects.

What is ctDNA?

ctDNA stands for circulating tumour DNA. It's tiny fragments of cancer DNA that can be found in your blood, and checking its levels can sometimes tell us more about the cancer.