FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074809 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 19/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Data registry for patients with rectal cancer treated with radiation and chemotherapy undergoing non operative management 
Scientific Title of Study   Evaluation of clinical outcome in Asian patients with localized rectal adenocarcinoma managed with watch-and-wait approach by developing a multinational collaborative database. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivakumar Gudi 
Designation  Assistant Professor, Radiation Oncology 
Affiliation  Tata Memorial Hospital 
Address  Department of Radiation Oncology, Tata Memorial Hospital, 10th floor, room no-1002, Dr Ernest Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  02224176863  
Fax    
Email  shivakumargudi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shivakumar Gudi 
Designation  Assistant Professor, Radiation Oncology 
Affiliation  Tata Memorial Hospital 
Address  Department of Radiation Oncology, Tata Memorial Hospital, 10th floor, room no-1002, Dr Ernest Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  02224176863  
Fax    
Email  shivakumargudi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shivakumar Gudi 
Designation  Assistant Professor, Radiation Oncology 
Affiliation  Tata Memorial Hospital 
Address  Department of Radiation Oncology, Tata Memorial Hospital, 10th floor, room no-1002, Dr Ernest Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  02224176863  
Fax    
Email  shivakumargudi@gmail.com  
 
Source of Monetary or Material Support  
Intramural funding, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Dr Ernest Borges Marg Parel Mumbai 400012 
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 Shivakumar Gudi  Tata Memorial Hospital  Department of Radiation Oncology 10th floor, Room no 1002, Tata Memorial Hospital, Dr Ernest Borges Marg Parel Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 02224176863

shivakumargudi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre, 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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Histologically confirmed diagnosis of adenocarcinoma of the rectum
2.Clinical stage T1-T4, N0-N2, M0 at diagnosis
3.ECOG Performance status 0-1
4.Neoadjuvant treatment with either short course or long course radiation therapy and / or chemotherapy
5.Complete or near complete clinical response after neoadjuvant therapy
6.Patients willing to be on watch-and-wait strategy.
7.The distance from anal verge of tumour up to 10 cm (Mid and low rectal tumours)
 
 
ExclusionCriteria 
Details  1.Recurrent rectal cancer
2.Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
3.Not willing to consent for the study or to follow up routinely
4.Patients who cannot read or understand the language of QoL
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the local regrowth rates at 2 years in Asian patients managed with the watch-and-wait strategy after neoadjuvant therapy in rectal cancer.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the rates of overall survival (OS) at 2 years and 5 years  2 years 
To determine disease free survival (DFS) at 2 years and 5 years  2 years 
To determine the rates of colostomy free survival at 2 years and 5 years  2 years 
To determine the clinical complete response rates (cCR) and regrowth rates with respect to various neoadjuvant treatment approaches  2 years 
To determine Quality of life (QOL) of patients managed with Watch-and-wait policy.  2 years 
To determine compliance of these patients to recommended surveillance protocol.  5 years 
 
Target Sample Size   Total Sample Size="337"
Sample Size from India="250" 
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)   15/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/01/2025 
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)
Modification(s)  		 Not Yet Recruiting 
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   The standard treatment approach of localized rectal adenocarcinoma involves neoadjuvant radiotherapy and chemotherapy followed by assessment for surgery and optional adjuvant chemotherapy. However, such patients who achieve complete of near complete clinical response after neoadjuvant therapy are increasingly being managed with the ‘Watch-and-Wait strategy’ in the recent years. Although safety of such policy has been established, the patient population in the published studies are not represented well by Asian population. Moreover, the data about safety of such policy in the setting of modern neoadjuvant strategies is limited. We propose a multinational collaborative prospective database study in Asia to systematically collect data on patients being managed with such a strategy. The target population is patients with localized rectal adenocarcinoma achieving near complete or complete response being managed by the Watch-and-Wait strategy. The primary end point being local regrowth and other survival and quality of life end points will be evaluated as well. A secure multinational database will be generated over 5 years with an estimated expected minimal sample size of 337 patients over 5 years across 7-10 Asian institutes to precisely evaluate the required endpoints. Ethical and legal requirements will be met at each participating institute. 
Close