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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Head Neck; Cancer of Prostate; Cancer Cervix
• Intervention / Treatment: Other: A web-based artificial intelligence (AI) auto-planning tool

• Study Type: Observational
• Enrollment (Estimated): 990

Contacts and Locations

• Study Contact: Name: ARCHERY Trial Manager; Phone Number: +442076704637; Email: mrcctu.archery@ucl.ac.uk

Study Locations

• India
  • Kolkata, India
    • Recruiting
    • Tata Medical Centre
    • Contact: Dr Mallick
  • Mumbai, India
    • Recruiting
    • Tata Memorial hospital
    • Contact: Dr Ghosh-Laskar
• Jordan
  • Amman, Jordan
    • Recruiting
    • King Hussein Cancer Center
    • Contact: Dr Mohamad
• Malaysia
  • Kuala Lumpur, Malaysia
    • Recruiting
    • University of Malaya Medical Center
    • Contact: Dr Malik
• South Africa
  • Cape Town, South Africa
    • Recruiting
    • Groote Schuur Hospital
    • Contact: Prof Parkes
  • Stellenbosch, South Africa
    • Not yet recruiting
    • Tygerberg hospital
    • Contact: Dr Trauernicht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for radiotherapy for head and neck, cervical or prostate cancer.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Head and Neck Neoplasms; Prostatic Neoplasms
• Other Study ID Numbers: ARCHERY (Other Identifier: San Raffaele Hospital); 1U01CA269143-01 (U.S. NIH Grant/Contract); 10678756 (Other Identifier: ISRCTN)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No