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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)

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ClinicalTrials.gov Identifier: NCT02629458
Recruitment Status : Completed
First Posted : December 14, 2015
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oncology Procedure: Treatment by Surgical resection Procedure: Stereotactic Ablative Radiotherapy (SABR) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients requiring surgery Procedure: Treatment by Surgical resection
Procedure: Stereotactic Ablative Radiotherapy (SABR)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  1. Primary tumour characteristics.

  2. 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

  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, endobronchial 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 complications from surgical resection
  5. Age ≥ 18
  6. 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
  7. Able and willing to provide written informed consent

Exclusion Criteria:

  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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS7 9TF
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site ISRCTN registry  This link exits the ClinicalTrials.gov site

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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
Additional relevant MeSH terms:
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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