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

Recruiting

• Conditions: Cancer of Prostate; Cancer Head Neck; Cancer Cervix

• Registration Number: NCT05653063
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-16
• Study Start: 2023-12-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Primary Completion: 2025-12-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 990

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Comparison of radiotherapy treatment costs using the artificial intelligence automated pathway and standard manual planning pathway	radiotherapy treatment plan preparation process and treatment interval

Trial Locations

Locations (6)

Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa

King Hussein Cancer Center; 🇯🇴 Amman, Jordan

University of Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia

Tygerberg Hospital; 🇿🇦 Stellenbosch, South Africa

Tata Memorial Hospital; 🇮🇳 Mumbai, India

Tata Medical Centre; 🇮🇳 Kolkata, India