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CTRI Number  CTRI/2026/04/107745 [Registered on: 07/04/2026] Trial Registered Prospectively
Last Modified On: 25/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing two types of Anaesthesia in cervical cancer Brachytherapy. 
Scientific Title of Study   A COMPARATIVE STUDY TO EVALUATE THE DIFFERENCES IN DOSIMETRY AND TREATMENT OUTCOMES IN PATIENTS WITH LOCALLY ADVANCED CARCINOMA CERVIX UNDERGOING INTRACAVITORY BRACHYTHERAPY UNDER TWO DIFFERENT ANAESTHESIA TECHNIQUES. 
Trial Acronym  DLACTA - ICBT Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPranabandhu Das 
Designation  Professor, MD Radiotherapy 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Radiation oncology, SVIMS, Tirupathi.

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547731  
Fax    
Email  daspranabandhu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPranabandhu Das 
Designation  Professor, MD Radiotherapy 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Radiation oncology, SVIMS, Tirupathi.

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547731  
Fax    
Email  daspranabandhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrPranabandhu Das 
Designation  Professor, MD Radiotherapy 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Radiation oncology, SVIMS, Tirupathi.

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547731  
Fax    
Email  daspranabandhu@gmail.com  
 
Source of Monetary or Material Support  
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES 
Address  Alipiri Road, Tirupati, Chittoor District, Andhra Pradesh, India Pin Code: 517501 Landmark: Opposite to ASWO Office, Alipiri,0877-2287777  
Type of Sponsor  Other [SELF] 
 
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 
Dr Medam Sravani  Sri Venkateswara Institute of Medical Sciences  Department of Radiation oncology, SVIMS, Tirupathi.
Chittoor
ANDHRA PRADESH 		 7794961555

medamsravani8699@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 
Intervention  EPIDURAL ANAESTHESIA  Dosimetry differences and treatment outcomes in patients undergoing ICRT under Epidural anaesthesia. 
Comparator Agent  PROCEDURAL SEDATION  Dosimetry differences and treatment outcomes in patients undergoing ICRT under Epidural anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  INCLUSION CRITERIA:
1. Age : 18 years or older
2. International Federation of Gynaecology and Obstetrics (FIGO) stage (11) : stage IB3,
II, III, IVA
3. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (PSS): 0-2
4. Patients who are willing to give informed consent to participate in the study. 
 
ExclusionCriteria 
Details  1. Carcinoma cervix patients who underwent surgery
2. Carcinoma cervix patients who underwent prior radiotherapy.
3.ECOG PSS : 3-4
4.Stage IVA disease with vesicovaginal fistula(VVF), rectovaginal fistula(RVF), stage
IVB
5. Pregnant women and lactating mothers 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the radiation dose received by 2cc (D2cc) bladder, rectum,
sigmoid colon between 2 study arms-epidural analgesia (ICBT-EA) vs procedural sedation (ICBT-PS). 		 During treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare
1. Pain intensity score by using numeric rating scalr (NRS)
2. Tumor response rate.
3. Late radiation toxicities – proctitis, cystitis. 		 During treatment, after 1 month, 3 months,6 months, 9 months, 12 months. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/04/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
AIM:
To evaluate efficacy and dosimetric superiority of epidural analgesia (EA) over procedural sedation (PS) in patients with locally advanced carcinoma cervix undergoing high dose rate intracavitory brachytherapy(HDR-ICBT).

OBJECTIVES: 
To compare the following parameters between 2 study arms-epidural analgesia (ICBT-EA) vs procedural sedation (ICBT-PS). 
Primary objective: 
To compare the radiation dose received by 2cc (D2cc) bladder, rectum, sigmoid colon between 2 study arms. 
Secondary objective: 
To compare
1. Pain intensity score by using numeric rating scalr (NRS)
2. Tumor response rate. 
3. Late radiation toxicities – proctitis, cystitis.

INCLUSION CRITERIA: 
1. Age : 18 years or older 
2. International Federation of Gynaecology and Obstetrics (FIGO) stage IB3, II, III, IVA 
3. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (PSS): 0-2 
 4. Patients who are willing to give informed consent to participate in the study.

 EXCLUSION CRITERIA: 
1. Carcinoma cervix patients who underwent surgery
2. Carcinoma cervix patients who underwent prior radiotherapy. 
3. ECOG PSS : 3-4
4. Stage IVA disease with vesicovaginal fistula (VVF), rectovaginal fistula (RVF), stage IVB 
5. Pregnant women and lactating mothers

SAMPLE SIZE
Sample size is calculated based on mean dose received by rectum in previous study.
Assuming, Alpha error of 0.05 (95% Confidence limit), Power of 80%, Ratio of EA vs PS group 1:1 
The number of subjects required in Arm A and Arm B was calculated to be 25 in each group. 
Hence total sample size is 50 subjects.
The study sample size - the patients who satisfy inclusion criteria and recruited during the study period. 


ASSESSMENT OF OBJECTIVES 
Dosimetric Data: 
Radiotherapy treatment plans will be generated on TPS computers for each patient in both arms. 
The dosimetric data i.e, the dose received by the OARs, D2cc of bladder, rectum, and sigmoid colon will be collected and recorded.
 Pain intensity: 
Pain intensity will be assessed using either Visual analog scale (VAS) or Numeric rating scale (NRS) . 
Clinical outcome measures: 
1. All study participants will be called for follow-up, first once a month for 3 months, then 3 monthly for the next 9 months, then 6 monthly thereafter.
 2. The tumor response for 3 months will be evaluated as per the Response Evaluation Criteria in Solid Tumors (RECIST) . 
 3. Acute and late toxicities will be evaluated as per the RTOG criteria.

DATA COLLECTION: 
All data related to study participants will be collected in the predesigned proforma.
 All the collected data from each study participant will be entered into Microsoft Excel. 

STATISTICAL ANALYSIS:
Data will be collected on a predesigned proforma and will be entered in Microsoft Excel Worksheet (Windows 11; Version 2021) and analysed using the Statistical Package for Social Science (SPSS) standard version 20 (IBM Corp. Released 2011. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.). All continuous variables such as dosimetric parameters will be summarised using Mean (SD) or Median (IQR) depending on the normality of the distribution. Categorical variables such as toxicities will be summarised using proportions. Comparison of continuous variables across study groups (EA group vs PS group) will be done using unpaired t-test. Comparison of categorical variables across study groups will be done using Chi square test. P-value of <0.05 will be considered statistically significant.
 
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