FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/05/013757 [Registered on: 08/05/2018] Trial Registered Retrospectively
Last Modified On: 02/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Therapy for Cancer at Stomach and Esophagous junction 
Scientific Title of Study   Neoadjuvant Chemotherapy vs Neoadjuvant Chemoradiotherapy for Resectable Carcinoma Gastroesophageal junction : 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  Dr Shivendra Singh 
Designation  Senior Consultant 
Affiliation  Rajiv Gandhi Cancer Research Institute; Rohini; Sector 5; Delhi 110085  
Address  Room no D-10; Ground floor; GI Oncosurgery Division; Surgical Oncology Department Rajiv Gandhi Cancer Research Institute; Rohini; Sector 5; Delhi 110085 North West DELHI 110085 India

North West
DELHI
110085
India 
Phone  9818975024  
Fax    
Email  singh.shivendra@rgcirc.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivendra Singh 
Designation  Senior consultant 
Affiliation  Rajiv Gandhi Cancer Research Institute; Rohini; Sector 5; Delhi 110085 North West DELHI 110085  
Address  Room no D-10; Ground floor; GI Oncosurgery Division; Surgical Oncology Department Rajiv Gandhi Cancer Research Institute; Rohini; Sector 5; Delhi 110085 North West DELHI 110085 India

North West
DELHI
110085
India 
Phone  9818975024  
Fax    
Email  singh.shivendra@rgcirc.org  
 
Details of Contact Person
Public Query  
Name  Dr Shivendra Singh 
Designation  Senior consultant 
Affiliation  Rajiv Gandhi Cancer Research Institute; Rohini; Sector 5; Delhi 110085 
Address  Room no D-10; Ground floor; Rajiv Gandhi Cancer Research Institute; Rohini; Sector 5; Delhi 110085 North West DELHI 110085 India

North West
DELHI
110085
India 
Phone  9818975024  
Fax    
Email  singh.shivendra@rgcirc.org  
 
Source of Monetary or Material Support  
Room No. D-10; Ground floor; Rajiv Gandhi Cancer Research Institute; Sector-5; Rohini; Delhi 110085 
 
Primary Sponsor  
Name  Dr Shivendra Singh 
Address  Room No. 3054; Ground floor; Rajiv Gandhi Cancer Research Institute; Sector-5; Rohini; Delhi 110085 
Type of Sponsor  Other [PRINCIPAL INVESTIGATOR] 
 
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 Shivendra Singh  Rajiv Gandhi Cancer Institute and Research Centre  Room No. 3054; Ground Floor;Surgical Oncology Department;D block;Rajiv Gandhi Cancer Institute and Research Centre;Sector 5; Rohini; Delhi 110085 North West DELH
North West
DELHI 		 9818975024

singh.shivendra@rgcirc.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Review Board of Rajiv Gancdhi Cancer Institute and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with resectable Carcinoma Gastroesophageal junction without clinical metastasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  chemotherapy will constitute cisplatin; 5-Flurouracil weekly with Radiotherapy (50.4 Gy in 28 fraction)  Chemotherapy will constitute cisplatin; 5-Flurouracil weekly concurrently with with Radiotherapy (50.4 Gy in 28 fractions) followed by surgery after 6 weeks. Common Terminology criteria for Adverse events (CTCAE) will be used to measure toxicity of both treatment regimens  
Intervention  DCF ( Docetaxel;cisplatin/carboplatin; 5- Flurouracil) based chemotherapy regimen   3 cycles of DCF ( Docetaxel;cisplatin/carboplatin; 5- Flurouracil) based chemotherapy regimen before surgery and 3 more cycles in adjuvant setting. surgery will be performed after 6 weeks from first 3 cycles.Common Terminology criteria for Adverse events (CTCAE) will be used to measure toxicity of both treatment regimens 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All patients with resectable and hitologically proven adenocarcinoma of Gastroesophageal junction(type I,II,III) who are fit for surgery(ECOG performance status 0,1,2); No Distant metastasis on PET scan and Staging Laparoscopy  
 
ExclusionCriteria 
Details  Distant metastasis on Staging Laparoscopy or on PET scan; refusal for informed consent for procedure; locally unresectable tumors; tumors falling in stage cT1N0 on Endoscopic ultrasound examination 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of median survival rates in patient treated with NACT followed by surgery with NACTRT followed by surgery  30 days from surgery ; 3 month; 6 month; 1 year; 3 years ; 5 years  
 
Secondary Outcome  
Outcome  TimePoints 
Pathological response; Progression free survival; number of R0 resections; treatment toxicity; quality of life  30 days from surgery ; 3 month; 6 month; 1 year; 3 years ; 5 years  
 
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)   27/04/2014 
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="5"
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   The study is a prospective , double arm, single centric, randomized control  trial  to compare Neoadjuvant Chemotherapy followede by surgery vs Neoadjuvant Chemoradiotherapy followed by surgery  for Resectable Carcinoma Gastroesophageal junction (seiwert type 1,2 and 3) in  50 consecutive patients   who  did not have distant metastasis on staging laparoscopy and had resectable disease locally. Our hypothesis is that there is no benefit in overall survival and complication rate between two groups. Our primary outcome would be to Compare of median survival rates in two groups  , and secondary outcome will be to measure Pathological response; Progression free survival; number of R0 resections; treatment toxicity; quality of life  of patients in two groups. Patients will be randomized to  either arms after completion of  workup and diagnostic laparoscopy  by computer generated method if no distant metastasis found. At present either chemotherapy or  chemoradiotherapy , both are  recommended by NCCN for neoadjuvant therapy for gastroesophageal junction adenocarcinomas before surgery. 
Close