Clinical trial NCT05653063: ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer
Official title: ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Prostate
Cancer Head Neck
Cancer Cervix
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Rising Tide Foundation
name: Medical Research Council
name: Tata Memorial Hospital
name: Tata Memorial Centre
name: University of Stellenbosch
name: King Hussein Cancer Center
name: University of Malaya
name: University Ghent
name: M.D. Anderson Cancer Center
name: Mount Vernon Cancer Centre at Mount Vernon Hospital
name: University of Cape Town
name: National Cancer Institute (NCI)
First posted: 2022-12-16
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for radiotherapy for head and neck, cervical or prostate cancer.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of radiotherapy treatment plans that have contours and dosimetry that meet pre-defined criteria for clinical acceptability
timeFrame: Prior to first treatment
Secondary outcomes:
measure: 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
timeFrame: radiotherapy plan preparation process pre treatment
measure: Comparison of radiotherapy treatment costs using the artificial intelligence automated pathway and standard manual planning pathway
timeFrame: radiotherapy treatment plan preparation process and treatment interval
Other outcomes:
Locations:
city: Kolkata
country: India
facility: Tata Medical Centre
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Amman
country: Jordan
facility: King Hussein Cancer Center
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Center
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Stellenbosch
country: South Africa
facility: Tygerberg Hospital
Study officials:
References: