Design and Evaluation of a Novel Methodology for SABR for Lung Cancer

June 15, 2021 updated by: Royal Surrey County Hospital NHS Foundation Trust

Design and Evaluation of a Novel Methodology for Stereotactic Ablative Radiotherapy for Lung Cancer: Reducing Treatment Side-effects and Enabling More Patients to Benefit From This Treatment

Aims: To increase the number of patients that benefit from Stereotactic Ablative Radiotherapy (SABR) for lung cancer using new treatment methods that reduce the amount of non-cancer tissue receiving a high radiation dose without affecting tumour dose coverage.

Background: SABR is a treatment for lung cancer which offers major advantages over conventional radiotherapy. It is a more precise highly effective treatment with significantly improved treatment outcomes (greater elimination of cancer cells).

SABR requires high doses per treatment so extreme accuracy is required to minimise healthy tissue damage. Normal breathing results in significant tumour movement, therefore to avoid missing the tumour, larger volumes need to be treated, resulting in more good tissue damage.

UK Standard practice requires the tumour to be irradiated in all positions during breathing whilst the new approach targets the tumours at the position it spends most time to minimise normal tissue affected by radiation.

Current practice for SABR patients would be improved (fewer severe radiation side-effects) and potentially could become a viable treatment for high risk patients.

Methods: 30 SABR patients receiving current standard SABR treatment will be recruited. This is an observation study in which patients will continue to receive standard of care but in addition:

  • A camera will be used to make videos of how the patient's chest moves in 3D at CT and treatment. I will build a complex mathematical model that infers movement of the tumour from movement of the chest.
  • Their breathing patterns, corresponding tumour motions and treatments plans will be utilised to develop a method for safely implementing the new treatment approach.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving SABR Lung Radiotherapy

Description

Inclusion Criteria:

All patients eligible for and who have consented to receive Lung SABR at the Royal Surrey County Hospital will be eligible for entry into this study.

• Over 18 years old (radiotherapy is not delivered to 16-18yr olds at RSFT). No upper age limit.

Exclusion Criteria:

Patients with irregular breathing motion resulting in failed 4DCT

  • Patients with unusual chest surface deformities
  • Patients who lack the capacity to consent
  • Patients unable to read and communicate in English

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Design a methodology that ensures tumour dose coverage is obtained when using the new treatment approach.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Use a novel markerless non-contact approach (Microsoft Kinect) to create a model to correlate external respiratory motion with internal tumour motion.
Time Frame: 2years
2years
Validate and refine correlation between predicted tumour motion and actual breathing motion.
Time Frame: 2years
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

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 (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19ONCN262953

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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