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CTRI Number  CTRI/2024/11/077406 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 22/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Esophageal Brachytherapy (ILRT) with Short course Hypofractionated accelerated EBRT versus EBRT alone in palliative treatment of esophageal cancers: a randomized phase III trial. (EBRISH trial) 
Scientific Title of Study   Esophageal Brachytherapy (ILRT) with Short course Hypofractionated accelerated EBRT versus EBRT alone in palliative treatment of esophageal cancers: a randomized phase III trial. (EBRISH trial) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Kumar Choubey 
Designation  Assistant Professor 
Affiliation  Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi 
Address  Department of Radiation Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi, Uttar Pradesh, India 221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8887596428  
Fax    
Email  ajaykc@mpmmcc.tmc.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ajay Kumar Choubey 
Designation  Assistant Professor 
Affiliation  Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi 
Address  Department of Radiation Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi, Uttar Pradesh, India 221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8887596428  
Fax    
Email  ajaykc@mpmmcc.tmc.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ajay Kumar Choubey 
Designation  Assistant Professor 
Affiliation  Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi 
Address  Department of Radiation Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi, Uttar Pradesh, India 221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8887596428  
Fax    
Email  ajaykc@mpmmcc.tmc.gov.in  
 
Source of Monetary or Material Support  
MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE,SUNDERBAGIYA NEAR NARIA GATE BHU CAMPUS VARANASI UTTAR PRADESH 221005 
 
Primary Sponsor  
Name  TMH TRAC 
Address  Tata Memorial Hospital Dr. E Borges Road, Parel, Mumbai - 400 012 
Type of Sponsor  Government funding agency 
 
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 Ajay Kumar Choubey  Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital  Department of Radiation Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi, Uttar Pradesh, India
Varanasi
UTTAR PRADESH 
8887596428

ajaykc@mpmmcc.tmc.gov.in 
 
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: C159||Malignant neoplasm of esophagus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  External Beam Radiation + Brachytherapy arm  Hypo fractionated external beam radiation to a dose of 12 Gy in 4 fractions over 2 days (twice daily) followed by Intraluminal brachytherapy to a dose of 12 Gy in 2 sessions of 6 Gy each. 
Comparator Agent  External beam radiation arm  External Beam Radiation to a dose of 30 Gy in 10 fractions over 2 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age more than 18 years
2. Metastatic esophageal cancer patients or patients not suitable for radical treatment (after MDT discussion)
3. Squamous cell carcinoma or adenocarcinoma of the esophagus
4. ECOG PS 0 to 3
5. Willing to give informed consent 
 
ExclusionCriteria 
Details  1. Upper extent of disease within 2 cm from upper esophageal sphincter
2. Lower extent of disease within 1 cm from gastroesophageal junction
3. ECOG PS 4
4. Deep ulceration
5. Trachea-esophageal fistula
6. Previous radiation therapy or surgery in the thoracic region.
7. Stents in situ before radiotherapy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Degree of dysphagia would be evaluated with physician assessed 5 points Ogilvie’s score. (primary outcome)  Ogilvie’s score-pretreatment, post-treatment, 1 month, 3 month and 6 months post treatment. (primary outcome)
 
 
Secondary Outcome  
Outcome  TimePoints 
2. Swallowing associated quality of life specific to the complaint of dysphagia would be evaluated with the EORTC QLC Oesophagus module
3. Treatment-associated toxicity would be associated with RTOG, CTCAE version 5 and patient-reported PRO-CTCAE.
4. Dysphagia-free survival would be calculated in responders with Kaplan Maier statistics
5. Overall survival would be calculated with Kaplan Maier statistics
6. Health-related quality of life would be evaluated with the EORTC QLC C15 PAL questionnaire. 7. Cost of treatment - collection of data like travel cost, accommodation cost, cost of procedure, total cost of treatment incurred 
2. EORTC Oesophagus module – pretreatment, post-treatment – 1 month, 3 months and 6 month
3. RTOG, CTCAE v5, and PRO-CTCAE toxicity score– post-treatment 1 month and 3 month
4. Dysphagia-free survival – from last day of RT to worsening of dysphagia score.
5. Overall survival – from the date of signing of informed consent to death
6. EORTC QLC C15 PAL – pretreatment, post-treatment 1 month, 3 months and 6 months 7. Cost of treatment – on the date of radiotherapy completion. 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   Phase 3 
Date of First Enrollment (India)   15/01/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Esophageal cancers often present late in their natural course of disease. In the advanced stages, many of the patients would not be suitable for treatment with a curative approach. Therefore, effective palliative treatment is necessary to decrease the burden of symptoms and improve quality of life. The ideal palliative regimen should have high rates of response with minimal toxicities. Also, patients should not be subjected to unnecessarily prolonged hospital visits. In a developing country like India, delivering effective palliative treatment with minimum hospital visits and out-of-pocket patient expenditure is crucial. One of the standard palliative external beam radiation regimens is 10 days of external beam radiotherapy (30 Grays in daily fractions over 2 weeks). However, this regimen requires at least 10 hospital visits. We wish to see if a 4 hospital visits radiation regimen combining shorter external beam radiotherapy (12 Grays in 4 fractions over 2 days, treated twice daily) with 2 sessions of intraluminal brachytherapy (12 Grays in 2 fractions) can produce potentially more relief of swallowing difficulty in esophageal patients. Decreasing treatment time would be beneficial for both the healthcare system and patients. This trial would compare the effectiveness, side effect profile, and improvement in quality of life of patients enrolled in both arms.

 
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