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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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