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

• Sponsor: University College, London (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05653063
• Collaborator: National Institutes of Health (NIH) (NIH), Rising Tide Foundation (Other), Medical Research Council (Other), Tata Memorial Hospital (Other), Tata Memorial Centre (Other), University of Stellenbosch (Other), King Hussein Cancer Center (Other), University of Malaya (Other), University Ghent (Other), M.D. Anderson Cancer Center (Other), Mount Vernon Cancer Centre at Mount Vernon Hospital (Other), University of Cape Town (Other), National Cancer Institute (NCI) (NIH)
• Enrollment: 990
• Anticipated Duration (Months): 42.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Prostate; Cancer Head Neck; Cancer Cervix	Other: A web-based artificial intelligence (AI) auto-planning tool

Study Design

• Study Type: Observational
• Anticipated Enrollment: 990 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Sep 1, 2026

Outcome Measures

Primary Outcome Measures

1. Proportion of radiotherapy treatment plans that have contours and dosimetry that meet pre-defined criteria for clinical acceptability [Prior to first treatment]

Secondary Outcome Measures

1. 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]

2. Comparison of radiotherapy treatment costs using the artificial intelligence automated pathway and standard manual planning pathway [radiotherapy treatment plan preparation process and treatment interval]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University College, London
• ClinicalTrials.gov Identifier: NCT05653063
• Other Study ID Numbers: ARCHERY; 1U01CA269143-01; 10678756
• First Posted: Dec 16, 2022
• Last Update Posted: Dec 16, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Head and Neck Neoplasms

Study Results

No Results Posted as of Dec 16, 2022