Condition category
Cancer
Date applied
04/02/2015
Date assigned
04/02/2015
Last edited
10/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mrs Catherine Lowe

ORCID ID

Contact details

Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18037

Study information

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.

Acronym

SABRTOOTH

Study hypothesis

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

NHS Health Research Authority, NRES Committee Yorkshire and The Humber - Leeds West, 22/09/2014, ref: 14/YH/1162

Study design

Both; Interventional and Observational; Design type: Treatment, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Recruitment rate/month over months 7-21

Secondary outcome measures

N/A

Overall trial start date

01/11/2014

Overall trial end date

31/01/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 54; UK Sample Size: 54

Participant 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

Recruitment start date

01/07/2015

Recruitment end date

31/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital (lead centre)
Leeds
LS9 7TF
United Kingdom

Trial participating centre

Bradford Teaching Hospitals NHS Foundation Trust
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

The James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

NHS Nottingham University Hospitals
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Trial participating centre

The Christie NHS Trust
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Leeds Teaching Hospitals NHS Trust

Sponsor details

Research & Development
34 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0046-2

Publication citations

Additional files

Editorial Notes

10/03/2016: Cancer Help UK lay summary link added. 05/02/2016: Publication reference added.