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

NCT05653063 | Recruiting

• 3 other identifiers: ARCHERY1U01CA269143-0110678756
• Study Type: observational
• Target: 990
• Locations: 4 countries
• Sites: 6

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.

Conditions

Cancer of Prostate; Cancer Head Neck; Cancer Cervix

Outcome Measures

Primary Outcomes (1)

• Proportion of radiotherapy treatment plans that have contours and dosimetry that meet pre-defined criteria for clinical acceptability

  Prior to first treatment

Secondary Outcomes (2)

• 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

Interventions

A web-based artificial intelligence (AI) auto-planning tool OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• Consecutive histologically confirmed primary cervical cancer patients (Stage IB-IIIB including pelvic node positive) that have given consent for radical radiotherapy.
• Consecutive histologically confirmed primary prostate cancer patients (T1-4N0M0) that have given consent for radical radiotherapy.
• Mental capacity to understand and consent to participate in the study.
• Patients aged ≥18years.

You may not qualify if:

• Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumour as possible.
• Patients receiving palliative radiotherapy
• Patients aged \< 18years.

Sponsors & Collaborators

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

Study Sites (6)

Tata Medical Centre

Kolkata, India

RECRUITING

Tata Memorial Hospital

Mumbai, India

RECRUITING

King Hussein Cancer Center

Amman, Jordan

RECRUITING

University of Malaya Medical Center

Kuala Lumpur, Malaysia

RECRUITING

Groote Schuur Hospital

Cape Town, South Africa

RECRUITING

Tygerberg Hospital

Stellenbosch, South Africa

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Head and Neck Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Central Study Contacts

ARCHERY Trial Manager

CONTACT

+442076704637; mrcctu.archery@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: December 16, 2022
• Study Start: December 7, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

ZA (2); IN (2); MY (1); JO (1)