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CTRI Number  CTRI/2022/11/047633 [Registered on: 24/11/2022] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   CT Image Based Closest-to-tumor Radiation in Cervical Cancer  
Scientific Title of Study   A Prospective Observational Study on CT Image Based Adaptive Brachytherapy in Locally Advanced Cervical Cancer Patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adhiraj Dandapat 
Designation  Post graduate trainee 
Affiliation  Department of Radiation Oncology, Chittaranjan National Cancer Institute 
Address  Department of Radiation Oncology, Chittaranjan National Cancer Institute, 37-S.P. Mukherjee Road, Kolkata

Kolkata
WEST BENGAL
700026
India 
Phone  9932711670  
Fax    
Email  dandapatadhiraj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Adhiraj Dandapat 
Designation  Post graduate trainee 
Affiliation  Chittaranjan National Cancer Institute  
Address  Department of Radiation Oncology, Chittaranjan National Cancer Institute, 37-S.P. Mukherjee Road, Kolkata

Kolkata
WEST BENGAL
700026
India 
Phone  9932711670  
Fax    
Email  dandapatadhiraj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Debarshi Lahiri  
Designation  Senior Consultant  
Affiliation  Chittaranjan National Cancer Institute  
Address  Department of Radiation Oncology, Chittaranjan National Cancer Institute, 37-S.P. Mukherjee Road, Kolkata

Kolkata
WEST BENGAL
700026
India 
Phone  7980831044  
Fax    
Email  debarshil@gmail.com  
 
Source of Monetary or Material Support  
Chittaranjan National Cancer Institute 37, S.P. MUKHERJEE ROAD KOLKATA-700026 
 
Primary Sponsor  
Name  Chittaranjan National Cancer Institute  
Address  37- S.P. Mukherjee Road Kolkata, West Bengal PIN-700026 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Adhiraj Dandapat   Chittaranjan National Cancer Institute   Department of Radiation Oncology,37-S.P.Mukherjee Road Kolkata West Bengal
Kolkata
WEST BENGAL 		 9932711670

dandapatadhiraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C538||Malignant neoplasm of overlappingsites of cervix uteri,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  1.Patients of cervical cancer sent from multidisciplinary tumor board after being proved on histopathology (squamous cell or adenocarcinoma) with FIGO stage IB2 to III
2.Eastern Cooperative Oncology Group performance status upto 2
3.Hemoglobin >10 gm%, Total leukocyte count> 4000 cells/cmm, Platelet count> 1,00,000 cells/cmm (initially or after correction by blood transfusion).
4.Liver function test- AST< 2×Upper normal limit, bilirubin <2×upper normal limit
Kidney function test- Serum creatinine<1.5 mg/dL and calculated creatinine clearance using the Cockroft-Gault formula >50 ml/min
5.Patient with no history or current clinical evidence of any hematological or bleeding disorders
6.No history of drug use which results in hematological toxicity
7.HBsAg, Anti-HCV, HIV-I & -II Antibody non-reactive patients.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the feasibility of delineating HR-CTV on CT image following IBS-GEC ESTRO-ABS recommendations & Pre- & Post-EBRT MRI images.
Computation of target coverage along with the doses received at Point A.
To compare the doses received by bladder, rectum & bowel as per volume-based dose prescription and Point A-based dose prescription.
 		 At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the treatment response & toxicity with special attention to Gastrointestinal (GI) & Genitourinary(GU) toxicity.
 		 At baseline,4 weeks,8weeks,12 weeks,6months,yearly  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Aim of this observational study is to evaluate feasibility of target delineation on CT image for image guided brachytherapy in cervical cancer along with dosimetric analysis & comparison between volume-based dose prescription & point A based dose prescription.The proposed prospective study will be carried out at the Department of Radiation Oncology, Chittaranjan National Cancer Institute,Kolkata. Patients accrued in the study as per inclusion and exclusion criteria, will receive brachytherapy after completion of external-beam radiotherapy. Periodic follow-up of patients will be done to assess the treatment response & toxicities with special attention to GI and GU toxicity.

 
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