Radiationtreatment planning for Cervical and Head andNeck cancer using machine

Recruiting

Conditions: Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx,

Registration Number: CTRI/2023/05/053119

Lead Sponsor: Medical Research Council University College London

Brief Summary: 50% of patients with cancer require radiotherapy during their disease course, however, only 10-40% of patients in low and middle-income countries (LMICs), have access to it. The current radiotherapy planning pathway is inefficient requiring several labor intensive processes and takes weeks to months to deliver in LMICs. This has contributed to long waiting times for treatment resulting in cancer progression, increased morbidity, and inferior survival outcomes. In addition, errors at each stage of radiotherapy planning can directly impact on patient outcomes in terms of survival and both short- and long-term toxicities. As well as a shortage of equipment, severe shortfalls in the specialized workforce needed to deliver radiotherapy has been identified as the most significant barrier to expanding radiotherapy capacity in LMICs.

The proposed study aims to test a novel Artificial intelligence (AI) based software which can automate two components of the radiotherapy planning pathway, 1. Outlining of anatomical areas that are at risk of tumor spread and at risk of radiation damage. 2. Definition of the position, size, and shape of the radiation beams. It has the potential to reduce the clinician time needed to outline treatment structures (from hours to minutes), reduce variation between clinicians in delineation (improve quality of plans), and support better use of human resources. We propose a 48-month prospective study to evaluate the quality and economic benefit of AI based automated radiotherapy treatment planning for cervical cancer and head and neck cancers, which are common in LMICs, and for which radiotherapy is the main curative treatment. The study will recruit 706 patients across six public sector cancer hospitals in India (n=2), Jordan (n=1), Malaysia (n=1), and South Africa (n=2) to ensure we include a broad range of patients, and the representativeness of the findings will support implementation of the software in LMICs. Patient partners have informed the scope, objectives, and design of the study, and will have an active role in the entire life cycle of the study including study conduct, and co-design of the planned results dissemination and public engagement activities.

If the study objectives are met, the AI based software will be offered as a not-for-profit web service to public sector state hospitals in LMICs to support rapid implementation in daily practice, and expansion of high-quality radiotherapy in these regions. This will improve access, and affordability of this key treatment option and directly addresses Rising Tideâ€™s mission to establish innovative approaches to improve survival and the quality of life of patients with cancer globally.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 990

Inclusion Criteria

Patients with: a.
Histologically confirmed head and neck cancers of the oropharynx, larynx, hypopharynx, and nasopharynx (American Joint Committee on Cancer (AJCC) Stage I to IVB) that have given consent for radical radiotherapy (with or without concurrent chemotherapy).
Patients can be included if they have had induction chemotherapy prior to radiotherapy.
Histologically confirmed primary cervical cancer (International Federation of Gynaecology and Obstetrics (FIGO)/AJCC Stage IB to IIIC1) that have given consent for radical radiotherapy (with or without concurrent chemotherapy).
Histologically confirmed primary prostate cancer (AJCC Stage I to IVB) that have given consent for radical radiotherapy.
Patients can be included if they have had prior chemotherapy or are taking a hormonal therapy for their prostate cancer.
Provide signed informed consent to participate in the study.3. Aged greater than or equal to 18 years.

Exclusion Criteria

Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumor as possible.
Patients receiving a palliative dose of radiotherapy.
Patients that have any metal implants within the treatment field e.g. hip prostheses.
Dental implants are acceptable.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall treatment plan acceptability	4 years
Plan acceptability between the manual plan and that generated by automated treatment planning	4 years

Secondary Outcome Measures

Name	Time	Method
Time and resource savings
Cost effectiveness

Trial Locations

Locations (3): HOMI BHABHA CANCER HOSPITAL & RESEARCH CENTRE
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Tata Medical Center
🇮🇳
Parganas, WEST BENGAL, India
Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
HOMI BHABHA CANCER HOSPITAL & RESEARCH CENTRE
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Dr Umesh Mahantshetty
Principal investigator
9819885774
drumeshm@gmail.com