ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer

Cancer of Prostate Clinical Trial

Official title:

ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653063
• Other study ID #: ARCHERY
• Secondary ID: 1U01CA269143-011
• Status: Recruiting
• Start date: December 7, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: May 2024
• Source: University College, London
• Contact: ARCHERY Trial Manager
• Phone: +442076704637
• Email: mrcctu.archery[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to look at whether an Artificial Intelligence (AI) based computer program can automate two components of the radiotherapy treatment pathway to a sufficient quality standard to enable its routine clinical use. The two components include the delineation (outlining) of anatomical areas that are at risk of tumour spread and at risk of radiation damage, and the definition of the position, size and shape of the radiation beams.

The AI-based computer programs have been developed to perform tasks that would normally require direct human involvement by oncologists and medical physicists. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy, which this study will test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 990
• Est. completion date: September 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Consecutive patients with histologically confirmed head and neck cancers of the oropharynx, larynx, hypopharynx and nasopharynx (Stage I-III) that have given consent for radical radiotherapy.

2. Consecutive histologically confirmed primary cervical cancer patients (Stage IB-IIIB including pelvic node positive) that have given consent for radical radiotherapy.

3. Consecutive histologically confirmed primary prostate cancer patients (T1-4N0M0) that have given consent for radical radiotherapy.

4. Mental capacity to understand and consent to participate in the study.

5. Patients aged =18years.

Exclusion Criteria:

1. Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumour as possible.

2. Patients receiving palliative radiotherapy

3. Patients aged < 18years.

Related Conditions & MeSH terms

• Cancer Cervix
• Cancer Head Neck
• Cancer of Prostate
• Head and Neck Neoplasms
• Prostatic Neoplasms

Intervention

Other:
• A web-based artificial intelligence (AI) auto-planning tool
The CT scan taken at the time of treatment planning is uploaded to a web server called the Radiotherapy planning assistant which automates the contouring of target organs and areas of high-risk disease as well as defining the size, shape and number of radiotherapy beams to treat the cancer. The final plan is downloaded to the local treatment planning system where the doses are recalculated and clinical peer review is undertaken before the plan can be used clinically. In this study patients will not be treated with the AI tool but the manual plan created by the local teams.

Locations

Country	Name	City	State
India	Tata Medical Centre	Kolkata
India	Tata Memorial Hospital	Mumbai
Jordan	King Hussein Cancer Center	Amman
Malaysia	University of Malaya Medical Center	Kuala Lumpur
South Africa	Groote Schuur Hospital	Cape Town
South Africa	Tygerberg Hospital	Stellenbosch

Sponsors (14)

Lead Sponsor	Collaborator
University College, London	King Hussein Cancer Center, M.D. Anderson Cancer Center, Medical Research Council, Mount Vernon Cancer Centre at Mount Vernon Hospital, National Cancer Institute (NCI), National Institutes of Health (NIH), Rising Tide Foundation, Tata Memorial Centre, Tata Memorial Hospital, University Ghent, University of Cape Town, University of Malaya, University of Stellenbosch

Countries where clinical trial is conducted

India,  Jordan,  Malaysia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of radiotherapy treatment plans that have contours and dosimetry that meet pre-defined criteria for clinical acceptability		Prior to first treatment
Secondary	comparison of time and human resource requirements between producing automated radiotherapy treatment plans using artificial intelligence and producing treatment plans using the standard manual pathway		radiotherapy plan preparation process pre treatment
Secondary	Comparison of radiotherapy treatment costs using the artificial intelligence automated pathway and standard manual planning pathway		radiotherapy treatment plan preparation process and treatment interval