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CTRI Number  CTRI/2014/04/004534 [Registered on: 09/04/2014] Trial Registered Retrospectively
Last Modified On: 04/04/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   a clinical study to compare stenting with radiotherapy versus stenting with chemoradiotherapy for advanced oesophageal carcinoma patients 
Scientific Title of Study   Palliative stenting with radiotherapy versus stenting with chemoradiotherapy for inoperable oesophageal carcinoma : a randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  V Arun kumar 
Designation  senior resident  
Affiliation  AIIMS 
Address  Room no -1007, 1 st floor,near director office, AIIMS New Delhi.

New Delhi
DELHI
110029
India 
Phone  9013980321  
Fax    
Email  arun_pgi@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  prof peush sahni  
Designation  professor  
Affiliation  AIIMS 
Address  Room no 1005, Department of GIsurgery 1st floor,above directors office,AIIMS, New Delhi.
Room no 1005, department of GI surgery 1st floor,above directors office,AIIMS, New Delhi
New Delhi
DELHI
110029
India 
Phone  9999646488  
Fax    
Email  peush_sahni@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr v arun kumar  
Designation  senior resident ,Mch GI Surgery 
Affiliation  AIIMS 
Address  room no - 111, aiims trauma centre New Delhi
c/o GI surgery seminar room room no - 1007, 1 st floor,near director office, AIIMS New Delhi.
New Delhi
DELHI
110029
India 
Phone  9013980321  
Fax    
Email  arun_pgi@yahoo.com  
 
Source of Monetary or Material Support  
NOT APPLICABLE 
 
Primary Sponsor  
Name  not applicable 
Address  not applicable 
Type of Sponsor  Other [not applicable] 
 
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 
DRVARUN KUMAR   AIIMS   Department of GI Surgery AIIMS Ansari nagar New Delhi
Central
DELHI 		 9013980321

arun_pgi@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee / Ethics sub- committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with inoperable oesophageal carcinoma (ECOG 1-3),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Radiotherapy alone  Radiotherapy of 30 Gy in 10 fractions over 12 days after oesophageal stenting 
Intervention  Radiotherapy and chemotherapy   Radiotherapy dose of 30 GY along with oral capecitabine for 12 days and cisplatin infusion on Day 1 to 3 and Day 10 to 12 will be given after endoscopic stenting 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  i) Oesophageal and gastro oesophageal junction cancer patients with
• Locally advanced unresectable cancer such as invasion of tracheobronchial tree, aorta, pulmonary vascular structures.
• Metastatic disease.
• Comorbid conditions or general health status precluding a major surgical procedure with grade III and IV dysphagia.
• Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
ii) Vocal cord palsy.
iii) Dysphagia grades 3 and 4.
iv) Biopsy proven carcinoma - both squamous cell and adenocarcinoma

 
 
ExclusionCriteria 
Details  i) Carcinoma of cervical oesophagus
ii) Patients who had already received prior radiation or chemo radiotherapy or any other modality of treatment.
iii) Patients unstable for endoscopic procedure and for radiotherapy/chemoradiotherapy due to severe co-morbid illness such as congestive heart failure, severe hepatic and renal failure.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
i) To compare relief of dysphagia and quality of life (QOL) in patients with inoperable oesophageal cancer treated with stenting followed by radiotherapy versus those treated with stenting followed by chemoradiotherapy  to measure QOL every two months till death 
 
Secondary Outcome  
Outcome  TimePoints 
i) To assess overall survival (OS) benefit of chemoradiotherapy following stenting versus radiotherapy following stenting in these patients.
ii) To assess treatment related complications between the two treated groups
 		 to find the overall survival benfit and treatment complications at the end of the study 
 
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   Phase 3 
Date of First Enrollment (India)   03/09/2012 
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)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT PUBLISHED  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

. Chemoradiotherapy combined with oesopha­geal stenting could improve the symptoms of dysphagia in patients with inoper­able oesophageal carcinoma and could prolong their survival as well. Some case control studies have shown that stenting with chemoradiotherapy  prolonged  survival and effectively improved  symptoms of dysphagia than stenting alone in patients with inoperable advanced oesophageal cancer. To date, there are no published randomised  studies examining relief of dysphagia and Health-related quality of life (HRQoL) in patients  with advanced oesophageal carcinoma treated with SEMS placement  and chemoradiotherapy. This randomised trial aims  to evaluate the potential efficacy of SEMS implantation and chemoradiotherapy in inoperable oesophageal carcinoma over stenting with radiotherapy alone.

 
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