Comparing stereotactic ablative radiotherapy with surgery in patients with peripheral stage I non small cell lung cancer considered at higher risk of complications from surgical resection.
| ISRCTN | ISRCTN13029788 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13029788 |
| Secondary identifying numbers | 18037 |
- Submission date
- 04/02/2015
- Registration date
- 04/02/2015
- Last edited
- 31/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Mrs Catherine Lowe
Scientific
Scientific
Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom
Study information
| Study design | Both; Interventional and Observational; Design type: Treatment, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific 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. |
| Study acronym | SABRTOOTH |
| Study objectives | This study aims to determine the feasibility and acceptability of performing a large-scale definitive randomised phase III trial comparing surgery with stereotactic ablative radiotherapy (SABR) for patients with peripheral Stage I non-small cell lung cancer (NSCLC) at higher risk from surgery in the UK. |
| Ethics approval(s) | NHS Health Research Authority, NRES Committee Yorkshire and The Humber - Leeds West, 22/09/2014, ref: 14/YH/1162 |
| Health condition(s) or problem(s) studied | Topic: Cancer; Subtopic: Lung Cancer; Disease: Lung (non-small cell) |
| Intervention | Patients will receive either Surgery or SABR. 1. Surgery: 1.1. Aim of surgical resection is a R0 resection. 1.2. Both thoracotomy and VATS (Video Assisted Thoracoscopic Surgery) are acceptable. 1.3. For high risk patients, a VATS approach is preferred (but not mandatory) 1.4. Confirmation of N0 stage either by EBUS-TBNA or mediastinoscopy before lung resection is recommended for lymph nodes >1cm in axial diameter and/or positive on PET/CT. 1.5. Confirmation of diagnosis of Non-Small Cell Carcinoma of the primary tumour either pre-operatively by image guided biopsy or intra-operatively by Frozen Section examination is recommended for those cases without pre-operative histology but not mandatory. 1.6. Recommended procedure is an anatomical resection – either a lobectomy or an anatomical segmentectomy. 1.7. Sub-lobar or wedge resection is acceptable if an anatomical resection is not deemed safe. 1.8. Sampling of at least 3 lobe-specific N2 nodal stations is recommended, though for wedge resections lymph node sampling is not mandated as, due to patient specific factors, the duration of the anaesthetic may need to be minimised. 1.9. Post-op analgesia and chest tube management is as per local unit protocols. 2. Stereotactic Ablative Radiotherapy (SABR): This will be primarily based on the accepted guidelines of the UK SABR consortium, with three dose schedules based on the location of the tumour. 4D-CT scanning is used to establish the extent of tumour motion due to respiration and cone beam CT/fiducial tracking to localise the target on the linear accelerator). Multiple beams >7 or VMAT ARC therapy can be used and doses are according to the position of the tumour. There will be 21 months of recruitment followed by 6 months of additional follow-up. Follow up will be at 6weeks, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months post treatment (or until 6 months after the final participant is randomised), there will also be a patient reported questionnaire at 15 months and 21 months post treatment. OS data will be captured at the end of the study for all participants via the National Cancer Data Repository (NCDR). |
| Intervention type | Other |
| Primary outcome measure | Recruitment rate/month over months 7-21 |
| Secondary outcome measures | N/A |
| Overall study start date | 01/11/2014 |
| Completion date | 31/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 54; UK Sample Size: 54 |
| Total final enrolment | 24 |
| Key inclusion criteria | Main study: 1. Histological and/or clinical and radiological diagnosis of NSCLC 2. Primary tumour characteristics: 2.1. 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 = “No Fly Zone”. 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 (See diagram below). 2.2. Maximal axial diameter ≤ 5 cm measured on lung windows on computed tomography. 3. 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, endo-bronchial ultrasound or oesophageal endoscopic ultrasound and demonstrate negative cytology and/or pathology. 4. 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 of complications from surgical resection. 5. Age ≥ 18 6. Female patients must satisfy the investigator that they are either not of childbearing potential or not pregnant (i.e. be willing to undergo a pregnancy test within 72hrs of surgery or day 1 of SABR treatment),. 7. Able and willing to provide written informed consent. Qualitative sub-study: 1. Approached to consider entry into the SABRTooth trial 2. Decided against participation in the SABRTooth trial/ dropped out after randomisation but before treatment 3. Willing and able to comply with requirements of this study protocol 4. Written informed consent obtained to participate in this study |
| Key exclusion criteria | Main study: 1. Previous radiotherapy within the planned treatment volume 2. History of clinically significant diffuse interstitial lung disease 3. Any history of concurrent or previous invasive malignancy that in the opinion of the investigator could impact on trial outcomes 4. Clinical or radiological evidence of metastatic spread 5. 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 6. Previous systemic therapies, including targeted and experimental treatments, for their current lung cancer diagnosis. Qualitative sub¬study: 1. Decline participation in this study 2. Unable to comply with requirements of this study protocol |
| Date of first enrolment | 01/07/2015 |
| Date of final enrolment | 31/01/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St James's University Hospital (lead centre)
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford
BD9 6RJ
United Kingdom
BD9 6RJ
United Kingdom
The James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
NHS Nottingham University Hospitals
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
The Christie NHS Trust
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
Leeds Teaching Hospitals NHS Trust
Hospital/treatment centre
Hospital/treatment centre
Research & Development
34 Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom
"ROR" |
https://ror.org/00v4dac24 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To maintain the scientific integrity of the trial, data will not be released prior to the first publication of the analysis of the primary endpoint, either for trial publication or oral presentation purposes, without the permission of the TSC. |
| IPD sharing plan | De-identified individual participant data datasets generated and/or analysed during the current study will be available upon request from the Clinical Trials Research Unit, University of Leeds (contact CTRU-DataAccess@leeds.ac.uk in the first instance). Data will be made available at the end of the trial, i.e. usually when all primary and secondary endpoints have been met and all key analyses are complete. Data will remain available from then on for as long as CTRU retains the data. CTRU makes data available by a 'controlled access' approach. Data will only be released for legitimate secondary research purposes, where the Chief Investigator, Sponsor and CTRU agree that the proposed use has scientific value and will be carried out to a high standard (in terms of scientific rigour and information governance and security), and that there are resources available to satisfy the request. Data will only be released in line with participants' consent, all applicable laws relating to data protection and confidentiality, and any contractual obligations to which the CTRU is subject. No individual participant data will be released before an appropriate agreement is in place setting out the conditions of release. The agreement will govern data retention, usually stipulating that data recipients must delete their copy of the data at the end of the planned project. The CTRU encourages a collaborative approach to data sharing, and believe it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, copies of key trial documents and any other information required to understand and reuse the released datasets. The conditions of release for aggregate data may differ from those applying to individual participant data. Requests for aggregate data should also be sent to the above email address to discuss and agree suitable requirements for release. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/12/2016 | Yes | No | |
| Results article | 12/11/2020 | 17/05/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
31/05/2022: Total final enrolment and IPD sharing statement added.
17/05/2022: Publication reference added.
12/12/2018: No publications found, verifying study status with principal investigator.
10/03/2016: Cancer Help UK lay summary link added.
05/02/2016: Publication reference added.
