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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)

Primary Purpose

Oncology

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Treatment by Surgical resection

Stereotactic Ablative Radiotherapy (SABR)

About this trial

This is an interventional treatment trial for Oncology

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Leeds Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients requiring surgery

Arm Description

Outcomes

Primary Outcome Measures

Acheivment of a 'steady state' of recruitment.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02629458

First Posted

December 10, 2015

Last Updated

July 10, 2019

Sponsor

The Leeds Teaching Hospitals NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT02629458

Brief Title

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

Acronym

SABRTOOTHv1

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

July 1, 2015 (Actual)

Primary Completion Date

January 31, 2017 (Actual)

Study Completion Date

January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Leeds Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oncology

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients requiring surgery

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Treatment by Surgical resection

Intervention Type

Procedure

Intervention Name(s)

Stereotactic Ablative Radiotherapy (SABR)

Primary Outcome Measure Information:

Title

Acheivment of a 'steady state' of recruitment.

Description

Time Frame

Rate of recruitment over months 7 to 21.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Leeds Teaching Hospitals NHS Trust

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS7 9TF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32736936

Citation

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.

Results Reference

derived

PubMed Identifier

32616595

Citation

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.

Results Reference

derived

Links:

URL

https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0046-2

Description

Related Info

URL

https://doi.org/10.1186/ISRCTN13029788

Description

ISRCTN registry

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