At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Lung Surgery (procedure), Radiation therapy (radiation)
- How long the study runs
- Study runs about 161 months (dates as stated)
- About the drug or intervention
- Lung Surgery — procedure: Sublobar Lung Resection · Radiation therapy — radiation: Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions
- Patient visit burden
- Not specified by the sponsor
In plain English
This study compares two treatments for non-small cell lung cancer: surgery to remove a small part of the lung (called sublobar resection) versus a precise, targeted form of radiotherapy given in high doses (called stereotactic ablative radiotherapy, or SAbR). It is for people whose tumour is small (4 cm or less), in the outer part of the lung, and who are at higher risk from major surgery. The study is run by the University of Texas Southwestern Medical Center.
Who can take part
- Adults over 18 who can give written informed consent
- Lung cancer confirmed by biopsy within the last 180 days
- Tumour 4 cm or smaller, at an early stage, in the outer part of the lung, with no sign of spread elsewhere
- Lymph nodes that look suspicious have been checked and found clear of cancer
- A thoracic surgeon has confirmed the tumour can be removed with sublobar surgery
- Being at higher risk for surgery, for example because of weaker lung function (such as FEV1 or DLCO at 50% or less of predicted), or a surgeon believes a larger operation would be poorly tolerated, or meeting two other listed risk factors (such as age 75 or over)
- Lung function tests done within the last 180 days
- No other invasive cancer in the last 3 years (some exceptions, like non-melanoma skin cancer)
- Not pregnant or breastfeeding
Who may not be able to
- Under 18
- Very poor general health (performance status greater than 3)
- Tumour with less than 50% solid component on scans
- Tumour larger than stated limits, or in a central part of the lung
- Cancer that has spread to other parts of the body
- Previous chemotherapy, radiotherapy or surgery for this lung cancer
- Previous lung surgery or chest radiotherapy on the same side
- Do not meet the higher-risk criteria for surgery
- Unable to understand or sign the consent form
What taking part involves
- • Participants are put into one of two groups: one receives sublobar resection (surgery removing a small section of the lung), the other receives stereotactic ablative radiotherapy (SAbR), which is highly focused high-dose radiotherapy
- • Further details of the treatment schedule are not stated — ask the trial team
Time commitment: Details such as number of visits, tests and how long taking part lasts are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 272
- Started
- 2015-07
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase3 - 272 participants
- • To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Middlesbrough - The James Cook University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC
More detail
Stereotactic Ablative Radiotherapy has been shown in single institution phase II and matched cohort studies to be effective at controlling primary early lung cancer. Recent pooled analysis of both the STARS and ROSEL randomized trials comparing SABR versus lobectomy have shown a significantly improved 3-year survival with SABR, giving further impetus for successful completion of a randomized trial . Pre-randomized trial- Patients will be screened and pre-randomized to either SR or SAbR. Informed consent will be obtained after patients are made aware of the randomized assignment. Despite pre-randomization prior to consent, patients maintain their right to accept or decline any/all study activities. Only consenting patients will be allowed to participate in study activities, including observation after either randomized treatments or observation after standard of care treatment, while those declining consent will be managed by their physician(s) off study.Patients will be accrued and followed for a minimum of 2-years after treatment.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ based on institutional norms
- ✓ a negative urine or serum pregnancy test
What the study is looking for
- ✓0 Inclusion Criteria
- ✓1 Age \> 18 years.
- ✓2 ECOG/Zubrod performance status (PS) 0, 1, or 2 (reference Appendix C).
- ✓3 Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities...
- ✓4 The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days prior to...
See the full criteria
Where Is This Study? (1 UK site)
The James Cook University Hospital
Middlesbrough TS4 2BW, United Kingdom
How to Get in Touch
Sarah Neufeld, MBA
Sponsor contactCONTACT
