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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04928755
• Other study ID #: 19ONCN262953
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: December 2023

Study information

• Verified date: June 2021
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: Gail Distefano, MSc
• Phone: 07746958658
• Email: gail.distefano[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Design a methodology that ensures tumour dose coverage is obtained when using the new treatment approach.		2 years
Secondary	Use a novel markerless non-contact approach (Microsoft Kinect) to create a model to correlate external respiratory motion with internal tumour motion.		2years
Secondary	Validate and refine correlation between predicted tumour motion and actual breathing motion.		2years