- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02629458
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)
July 10, 2019 updated by: The Leeds Teaching Hospitals NHS Trust
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
Stage I non-small cell lung cancer (NSCLC) is curable and surgery is considered the standard of care for fit, good performance status patients.
However, a high proportion of patients with stage 1 NSCLC are elderly and/or have medical co-morbidities and are therefore at higher risk of surgical complications.
The optimal treatment for these patients is unknown.
SABR may be an equally appropriate treatment but this need to be formally assessed.
Funded by the NIHR Research for Patient Benefit, SABRtooth is a UK multi-centre, two-group individually randomised controlled feasibility study of patients with peripheral stage I non-small cell lung cancer considered at higher risk from surgery.
In total, 54 patients are planned to be recruited from 4 treatment sites and 2 referral sites.
This study aims to determine the feasibility and acceptability of performing a largescale definitive randomised phase III trial comparing surgery with stereotactic ablative radiotherapy (SABR).
The qualitative substudy is an exploration of the reasons for nonparticipation in the SABRTooth trial.
As the two treatments are very different, patients may have a strong preference for either surgery or SABR, or may feel uncomfortable to have a decision between such distinct options taken out of their hands.
Understanding why patients choose not to participate or do not take up their treatment allocation will be crucial in demonstrating that recruiting to a larger scale phase III trial is feasible.
We will explore what patients, who have declined particpation in the study or who intiailly consented but subsequently fail to take up their randomimsed treatment arm, understand, perceive and feel about, how the SABRTooth trial was presented to them and their expectations of study burden.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Yorkshire
-
Leeds, West Yorkshire, United Kingdom, LS7 9TF
- Leeds Teaching Hospitals NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary tumour characteristics.
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients requiring surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Rate of recruitment over months 7 to 21.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Elbanna M, Shiue K, Edwards D, Cerra-Franco A, Agrawal N, Hinton J, Mereniuk T, Huang C, Ryan JL, Smith J, Aaron VD, Burney H, Zang Y, Holmes J, Langer M, Zellars R, Lautenschlaeger T. Impact of Lung Parenchymal-Only Failure on Overall Survival in Early-Stage Lung Cancer Patients Treated With Stereotactic Ablative Radiotherapy. Clin Lung Cancer. 2021 May;22(3):e342-e359. doi: 10.1016/j.cllc.2020.05.024. Epub 2020 Jun 2.
- Franks KN, McParland L, Webster J, Baldwin DR, Sebag-Montefiore D, Evison M, Booton R, Faivre-Finn C, Naidu B, Ferguson J, Peedell C, Callister MEJ, Kennedy M, Hewison J, Bestall J, Gregory WM, Hall P, Collinson F, Olivier C, Naylor R, Bell S, Allen P, Sloss A, Snee M. SABRTooth: a randomised controlled feasibility study of stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I nonsmall cell lung cancer considered to be at higher risk of complications from surgical resection. Eur Respir J. 2020 Nov 12;56(5):2000118. doi: 10.1183/13993003.00118-2020. Print 2020 Nov.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
January 31, 2017
Study Completion (Actual)
January 31, 2017
Study Registration Dates
First Submitted
December 10, 2015
First Submitted That Met QC Criteria
December 11, 2015
First Posted (Estimate)
December 14, 2015
Study Record Updates
Last Update Posted (Actual)
July 12, 2019
Last Update Submitted That Met QC Criteria
July 10, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MO14/11248
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oncology
-
State University of New York at BuffaloRecruitingMedical Oncology | Integrative Oncology | Medical Nutrition TherapyUnited States
-
State University of New York at BuffaloRecruitingMedical Oncology | Integrative Oncology | Medical Nutrition TherapyUnited States
-
MaineHealthTufts Medical CenterRecruitingOncology | Prehabilitation | Surgical OncologyUnited States
-
AmgenCompletedCancer | Advanced Solid Tumors | Oncology | Tumors | Advanced Malignancy | Oncology PatientsUnited States
-
AmMax Bio, Inc.CompletedCancer | Advanced Solid Tumors | Oncology | Tumors | Advanced Malignancy | Oncology PatientsUnited States
-
AmgenCompletedCancer | Advanced Solid Tumors | Oncology | Tumors | Advanced Malignancy | Oncology PatientsUnited States
-
Royal Marsden NHS Foundation TrustRecruiting
-
GuerbetRecruitingOncologyAustria, France, Switzerland
-
Centre Hospitalier Regional de HuyCompleted
Clinical Trials on Treatment by Surgical resection
-
University Hospital, GenevaCentre Hospitalier Universitaire VaudoisUnknownIntestinal ObstructionSwitzerland
-
M.D. Anderson Cancer CenterTerminatedBreast CancerUnited States
-
Qazvin University Of Medical SciencesUnknownOral Lichen PlanusIran, Islamic Republic of
-
Sahlgrenska University Hospital, SwedenVastra Gotaland RegionRecruiting
-
Zagazig UniversityCompleted
-
Sun Yat-sen UniversityGuangdong Provincial People's Hospital; Second Military Medical UniversityUnknown
-
Fondazione Policlinico Universitario Agostino Gemelli...Technische Universität Dresden; University of Debrecen; Koc University Hospital; Hospital de la Santa creu i Sant Pau - Barcelona and other collaboratorsNot yet recruiting
-
Fudan UniversityShanghai Pulmonary Hospital, Shanghai, China; Zhoupu Hospital, Pudong New Area... and other collaboratorsRecruitingLung Adenocarcinoma | Surgical Procedure, Unspecified | PathologyChina
-
Grupo Espanol de Trabajo en Enfermedad de Crohn...Recruiting
-
University Hospital, ToursRecruiting