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Looking for participantsPhase3

JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer

Sponsor: University of Texas Southwestern Medical Center

NCT ID: NCT02468024

View on ClinicalTrials.gov ↗

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.

Non-Small Cell Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

or positiveconfirmed negativemethave a negative

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
1.0 Inclusion Criteria 1.1 Age \> 18 years. 1.2 ECOG/Zubrod performance status (PS) 0, 1, or 2 (reference Appendix C). 1.3 Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater. 1.4 The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days prior to randomization. 1.5 Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET or PET integrated with a simultaneous CT scan (PET-CT) of the chest and upper abdomen performed within 180 days prior to randomization (reference Appendix A \& B). Repeat imaging within 90 days prior to randomization is recommended for re-staging but is not required based on institutional norms. 1.6 All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (\> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, EUS/EBUS guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy within 180 days of randomization. 1.7 Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection. 1.8 Tumor located peripherally within the lung. NOTE: Peripheral is defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions. See bronchial tree diagram below. Patients with non-peripheral (central) tumors are NOT eligible. 1.9 No evidence of distant metastases. 1.10 Availability of pulmonary function tests (PFTs - spirometry, DLCO, +/- arterial blood gases) within 180 days prior to registration. Patients with tracheotomy, etc, who are physically unable to perform PFTs (and therefore cannot be tested for the Major criteria in 3.1.11 below) are potentially still eligible if a study credentialed thoracic surgeon documents that the patient's health characteristics would otherwise have been acceptable for eligibility as a high risk but nonetheless operable patient (in particular be eligible for sublobar resection). 1.11 To define eligibility of patients being at high risk for surgery, certain criteria must be met. Any one (1) of the following major criteria will define the high risk status for eligibility: Major Criteria * FEV1 ≤ 50% predicted (pre-bronchodilator value) * DLCO ≤ 50% predicted (pre-bronchodilator value) * Study credentialed thoracic surgeon believes the patient is potentially operable but that a lobectomy or pneumonectomy would be poorly tolerated by the patient for tangible or intangible reasons. The belief must be declared and documented in the medical record prior to randomization. If any of the major criteria are met, the patient is eligible based on high risk for surgery and minor criteria do not need to be considered. However, if no major criteria is met, at least two (2) minor criteria being met will also define eligibility for meeting the high risk status. Any two (2) of the following minor criteria will define the high risk status for eligibility: * Minor Criteria * Age ≥75 * FEV1 51-60% predicted (pre-bronchodilator value) * DLCO 51-60% predicted (pre-bronchodilator value) * Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mm Hg) as estimated by echocardiography or right heart catheterization * Poor left ventricular function (defined as an ejection fraction of 40% or less) * Resting or Exercise Arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88% * pCO2 \> 45 mm Hg * Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3. 1.12 No prior intra-thoracic radiation therapy for previously identified intra-thoracic primary tumor (e.g. previous lung cancer) on the ipsilateral side. NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted to the ipsilateral side so long as possible radiation fields would not overlap. NOTE: Radiotherapy to the contralateral lung is allowed so long as it was completed more than 3 years prior to randomization and there is no overlap of radiation fields. 1.13 Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted. 1.14 No prior lung resection on the ipsilateral side. 1.15 Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Peri-menopausal women must be amenorrheic \> 12 months prior to registration to be considered not of childbearing potential. 1.16 No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers). 1.17 Ability to understand and sign a written informed consent. 2.0 Exclusion Criteria 2.1 Age \<18 2.2 ECOG/Zubrod performance status (PS) greater than 3. 2.3 Radiographic findings with ground glass opacities and less than 50% solid component will be excluded. 2.4 The primary tumor in the lung, biopsy confirmed non-small cell lung cancer greater than 180 days prior to randomization. 2.5 Tumor \> 5 cm maximum diameter, including clinical stage IA and selected IB by PET or PET integrated with a simultaneous CT scan (PET-CT) of the chest and upper abdomen and/or performed greater than 180 days prior to randomization. 2.6 Lymph node biopsy greater than 180 days prior to randomization. 2.7 Thoracic surgeon confirms unable to remove tumor with sublobar resection. 2.8 Tumor located non-peripheral (central) region of lung (see bronchial tree diagram in 3.1.8). 2.9 Evidence of distant metastases. 2.10 Pulmonary function test (PFT - spirometry, DLCO, +/- arterial blood gases) greater than 180 days prior to registration. Patients physically unable to perform PFT's, such as patients with tracheotomy, that do not have written documentation from study credentialed thoracic surgeon stating eligibility. 2.11 Patients that do not meet either Major criteria or Minor criteria. 2.12 Prior intra-thoracic radiation therapy on ipsilateral side. Radiotherapy to the contralateral lung completed less than 3 years prior to randomization, with radiation field overlap. 2.13 Prior chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol. 2.14 Prior lung resection on the ipsilateral side. 2.15 Pregnant and lactating women. 2.16 Prior invasive malignancy and less than 3 years disease free prior to registration (unless non-melanoma skin cancer, in-situ cancers). 2.17 Unable to understand and/ or sign a written informed consent.

Where Is This Study? (1 UK site)

The James Cook University Hospital

Middlesbrough TS4 2BW, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Research and Development

stees.dtvra@nhs.net01642 854089

How to Get in Touch

Sarah Neufeld, MBA

Sponsor contact

CONTACT

214-645-8525 sarah.hardee@UTSouthwestern.edu
Data sourced from ClinicalTrials.gov · Last verified: 2026-04