A Study to Determine the Feasibility and Acceptability of Conducting a Phase III Randomised Controlled Trial Comparing Stereotactic Ablative Radiotherapy With Surgery in paTients With Peripheral Stage I nOn-small Cell Lung Cancer cOnsidered Higher Risk of Complications From Surgical Resection (SABRTOOTHv1)
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ClinicalTrials.gov Identifier: NCT02629458 |
Recruitment Status :
Completed
First Posted : December 14, 2015
Last Update Posted : July 12, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Oncology | Procedure: Treatment by Surgical resection Procedure: Stereotactic Ablative Radiotherapy (SABR) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study to Determine the Feasibility and Acceptability of Conducting a Phase III Randomised Controlled Trial Comparing Stereotactic Ablative Radiotherapy (SABR) With Surgery in paTients With Peripheral Stage I nOn-small Cell Lung Cancer (NSCLC) cOnsidered Higher Risk of Complications From Surgical Resection |
Actual Study Start Date : | July 1, 2015 |
Actual Primary Completion Date : | January 31, 2017 |
Actual Study Completion Date : | January 31, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Patients requiring surgery |
Procedure: Treatment by Surgical resection Procedure: Stereotactic Ablative Radiotherapy (SABR) |
- Acheivment of a 'steady state' of recruitment. [ Time Frame: Rate of recruitment over months 7 to 21. ]Recruitment rate/month over months 7-21 Recruitment rate/month over months 7-21 In order to demonstrate that recruitment targets for the main trial can be met within an adequate timeframe, the key objective of this feasibility study, a 'steady state' of recruitment must be observed. A formal monitoring of recruitment period will begin 6 months after the start of recruitment (allowing a run-in period for set-up), and an average of 3 patients per month must be recruited (randomised) over a consecutive 15 month period (a minimum of 45 patients) in order to demonstrate a 'steady state' of recruitment

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primary tumour characteristics.
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Peripherally located tumour as defined in the RTOG 0236 study and UK SABR Consortium guidelines. This states that the tumour must be more than 2cm in axial diameter from a major airway.
- This includes the trachea, carina, right and left main bronchus and extends to the bifurcation of the right upper, right middle, right lower, left upper and left lower lobe bronchioles
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No evidence of hilar or mediastinal lymph nodes involvement.
- Any hilar or mediastinal lymph nodes that are either
- PET positive or >1cm in axial dimension must be sampled by mediastinoscopy, endobronchial ultrasound or oesophageal endoscopic ultrasound and demonstrate negative cytology and/or pathology
- Local lung cancer MDT consensus opinion that patient is considered suitable for either surgical resection or SABR treatment AND also to be at higher risk complications from surgical resection
- Age ≥ 18
- Female patients must satisfy the investigator that they are not pregnant (negative pregnancy test within 72hrs of surgery of day 1 surgery/SABR), or are not of childbearing potential
- Able and willing to provide written informed consent
Exclusion Criteria:
- Previous radiotherapy within the planned treatment volume.
- History of clinically significant diffuse interstitial lung disease
- Any history of concurrent or previous invasive malignancy that in the opinion of the investigator could impact on trial outcomes
- Clinical or radiological evidence of metastatic spread
- History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
- Previous systemic therapies, including targeted and experimental treatments, for their current lung cancer diagnosis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629458
United Kingdom | |
Leeds Teaching Hospitals NHS Trust | |
Leeds, West Yorkshire, United Kingdom, LS7 9TF |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | The Leeds Teaching Hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT02629458 |
Other Study ID Numbers: |
MO14/11248 |
First Posted: | December 14, 2015 Key Record Dates |
Last Update Posted: | July 12, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |