CTRI Number |
CTRI/2023/05/053119 [Registered on: 24/05/2023] Trial Registered Prospectively |
Last Modified On: |
22/01/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Radiation
treatment planning for Cervical and Head and
Neck cancer using machine |
Scientific Title of Study
Modification(s)
|
A prospective observational study of artificial intelligence based radiotherapy treatment planning for cervical, head and neck and prostate cancer. |
Trial Acronym |
ARCHERY |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sarbani Ghosh Laskar |
Designation |
Professor Radiation Oncologist |
Affiliation |
Tata Memorial Hospital |
Address |
Room number 1126,11th floor,
Homi Bhabha Block,
Tata Memorial Hospital
Parel
Mumbai MAHARASHTRA 400012 India |
Phone |
9820834386 |
Fax |
24146937 |
Email |
sarbanilaskar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sarbani Ghosh Laskar |
Designation |
Professor Radiation Oncologist |
Affiliation |
Tata Memorial Hospital |
Address |
Room number 1126,11th floor,
Homi Bhabha Block,
Tata Memorial Hospital
Parel
Mumbai MAHARASHTRA 400012 India |
Phone |
9820834386 |
Fax |
24146937 |
Email |
sarbanilaskar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sarbani Ghosh Laskar |
Designation |
Professor Radiation Oncologist |
Affiliation |
Tata Memorial Hospital |
Address |
Room number 1126,11th floor,
Homi Bhabha Block,
Tata Memorial Hospital
Parel
Mumbai MAHARASHTRA 400012 India |
Phone |
9820834386 |
Fax |
24146937 |
Email |
sarbanilaskar@gmail.com |
|
Source of Monetary or Material Support
|
No funding required as no expenses involved in the interventional arm i.e transthyroid cartilage electrode which is available with the neuromonitoring system |
|
Primary Sponsor
|
Name |
Medical Research Council University College London |
Address |
Max Parmar, MRC CTU at UCL Director, MRC CTU at UCL, Institute of Clinical Trials & Methodology, 90 High Holborn 2nd Floor, London, WC1V 6LJ |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
Jordan India Malaysia South Africa |
Sites of Study
Modification(s)
|
No of Sites = 3 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Umesh Mahantshetty |
HOMI BHABHA CANCER HOSPITAL & RESEARCH CENTRE |
Marripalem, Aganampudi Village, Gajuvaka Mandalam, NH16, Visakhapatnam, Andhra Pradesh 530053 Visakhapatnam ANDHRA PRADESH |
9819885774 - drumeshm@gmail.com |
Dr Indranil Mallick |
Tata Medical Center |
Tata Medical Center
14 MAR (E-W), New Town, Rajarhat, Kolkata 700 160,
West Bengal, India. North Twentyfour Parganas WEST BENGAL |
9831171235
indranil.mallick@tmckolkata.com |
Dr Sarbani Ghosh Laskar |
Tata Memorial Hospital |
OPD 205 206 HBB
OPD 109 GJB
Tata Memorial Hospital
Parel Mumbai MAHARASHTRA |
9820834386
sarbanilaskar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 4 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE |
Approved |
Institutional Ethics Committee- 1, Tata Memorial Centre |
Approved |
Institutional Ethics Committee- 1, Tata Memorial Centre |
Approved |
Institutional Review Board, Tata Medical Center |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C539||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, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Not Applicable |
Not Applicable |
Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. 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.
OR
b. 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). Patients can be included if they have had induction chemotherapy prior to radiotherapy.
OR
c. 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.
2. Provide signed informed consent to participate in the study.3. Aged greater than or equal to 18 years. |
|
ExclusionCriteria |
Details |
1. Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumor as possible.
2. Patients receiving a palliative dose of radiotherapy.
3. Patients that have any metal implants within the treatment field e.g. hip prostheses. Dental implants are acceptable. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Overall treatment plan acceptability
Plan acceptability between the manual plan and that generated by automated treatment planning |
4 years |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time and resource savings
|
4 years |
Cost effectiveness
|
4 years |
|
Target Sample Size
Modification(s)
|
Total Sample Size="990" Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
05/06/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
05/06/2023 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="4" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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 Tide’s mission to establish innovative approaches to improve survival and the quality of life of patients with cancer globally. |