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CTRI Number  CTRI/2025/02/081061 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing pathological complete response rate after Short Course Radiochemotherapy vs. Long Course Chemoradiotherapy Before Surgery in Locally Advanced Rectal Cancer patients. 
Scientific Title of Study   A PROSPECTIVE RANDOMISED STUDY TO COMPARE SEQUENTIAL SHORT COURSE RADIOCHEMOTHERAPY VERSUS CONCURRENT LONG COURSE CHEMORADIOTHERAPY BEFORE TOTAL MESORECTAL EXCISION IN LOCALLY ADVANCED RECTAL CANCER. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR AJAY KUMAR BANSAL 
Designation  Junior Resident 
Affiliation  Post graduate institute of medical education and research chandigarh 
Address  Department of radiotherapy, nehru hospital extension,room no-54, post graduate institute of medical sciences, chandigarh,160012

Chandigarh
CHANDIGARH
160012
India 
Phone  7727935736  
Fax    
Email  drbansal999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR.RAKESH KAPOOR 
Designation  Professor 
Affiliation  Post graduate institute of medical education and research chandigarh 
Address  Department of radiotherapy, nehru hospital extension,room no-54, post graduate institute of medical sciences, chandigarh,160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9872648344  
Fax    
Email  drkapoor.r@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR AJAY KUMAR BANSAL 
Designation  Junior resident 
Affiliation  Post graduate institute of medical education and research chandigarh 
Address  Department of radiotherapy, nehru hospital extension,room no-54, post graduate institute of medical sciences, chandigarh,160012

Chandigarh
CHANDIGARH
160012
India 
Phone  7727935736  
Fax    
Email  drbansal999@gmail.com  
 
Source of Monetary or Material Support  
Department of radiotherapy, nehru hospital extension,room no-54, post graduate institute of medical sciences, chandigarh,160012  
 
Primary Sponsor  
Name  Department of radiotherapy pgimer chandigarh 
Address  Department of radiotherapy, nehru hospital extension,room no-54, post graduate institute of medical sciences, chandigarh,160012 
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 
DR AJAY KUMAR BANSAL  Post graduate institute of medical education and research chandigarh  Department of radiotherapy, Nehru hospital extension,room no-54, Post Graduate institute of medical sciences, chandigarh,1600122
Chandigarh
CHANDIGARH 		 7727935736

drbansal999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER Chandigarh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Concurrent long course chemoradiotherapy before total mesorectal excision in locally advanced rectal cancer.  Standard neoadjuvant therapy (NAT) for locally advanced rectal includes neoadjuvant chemoradiotherapy (CRT) which include 50.4GY in 28 fractions 5.5 weeks with concomitant capecitabine (825mg/m2) twice daily followed by TOTAL MESORECTAL EXCISION within 6-10 weeks. 
Intervention  Sequential short course radiochemotherapy before total mesorectal excision in locally advanced rectal cancer.  Total neoadjuvant therapy includes neoadjuvant short course radiotherapy (SCRT) which is 25GY in 5 fractions over a week followed by 6 cycles of FOLFOX 2 weekly subsequently succeeded by TOTAL MESORECTAL EXCISION within 6-10 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. ECOG 0-1
2. Biopsy proven case of locally advanced rectal adenocarcinoma
3. Pelvic MRI has atleast one the following features:
(i)Clinical tumour stage cT3, cT4a or cT4b
(ii)Nodal stage cN1, cN2
(iii)Involvement of mesorectal fascia
 
 
ExclusionCriteria 
Details  1.Metastatic disease
2.Recurrent rectal cancer
3.Uncontrolled medical comorbidities
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To compare the local disease control rate with these two treatments.
2.To compare the pathological complete response rate in two treatment groups.
 		 At completion of treatment and at 3 months after treatment.  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the acute and chronic toxicities with these two treatment arms.  During treatment and at 3 months after treatment. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   05/03/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Total neoadjuvant therapy (TNT) versus neoadjuvant therapy (NAT) is debated topic. But the recent work in some studies on LARC showed that the disease related treatment failure chances were decreased in patients receiving TNT in comparison to “standard neoadjuvant therapy (NAT)”. Total neoadjuvant therapy also lowers the risk of distant metastasis. Time taken between completion of “total neoadjuvant therapy” and surgery in patients with LARC is still under investigation. But the time gap of 8-12 weeks is associated with better pathological response. So, we in this study aim at decreasing the risk of distant metastasis without increasing the risk of LRR rates, thus ultimately improving survival outcomes and quality of life of patients.


 
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