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CTRI Number  CTRI/2022/09/045291 [Registered on: 07/09/2022] Trial Registered Prospectively
Last Modified On: 05/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomized Study Comparing complete Chemo-radiotherapy Before Surgery Versus Conventional Preoperative Chemo-radiotherapy Followed by Surgery and Chemotherapy in Locally Advanced Rectal Cancer 
Scientific Title of Study   A Prospective Randomized Study Comparing Total Neoadjuvant Treatment Followed by Total Mesorectal Excision (TME) and Conventional Long Course Chemoradiotherapy Followed By TME And Adjuvant Chemotherapy in Locally Advanced Rectal Cancer 
Trial Acronym  ReCTON Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Charan Singh 
Designation  Mch resident, Surgical Oncology 
Affiliation  KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY 
Address  ROOM NO 5, 4th floor, DEPARTMENT OF SURGICAL ONCOLOGY, OPD BLOCK, INFOSYS BUILDING
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, Dr. M.H. MARIGOWDA ROAD
Bangalore
KARNATAKA
560029
India 
Phone  9878940935  
Fax    
Email  charansinghgoyat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Charan Singh 
Designation  Mch resident, Surgical Oncology 
Affiliation  KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY 
Address  ROOM NO 5, 4th floor, DEPARTMENT OF SURGICAL ONCOLOGY, OPD BLOCK, INFOSYS BUILDING
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, Dr. M.H. MARIGOWDA ROAD
Bangalore
KARNATAKA
560029
India 
Phone  9878940935  
Fax    
Email  charansinghgoyat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Charan Singh 
Designation  Mch resident, Surgical Oncology 
Affiliation  KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY 
Address  ROOM NO 5, 4th floor, DEPARTMENT OF SURGICAL ONCOLOGY, OPD BLOCK, INFOSYS BUILDING
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, Dr. M.H. MARIGOWDA ROAD
Bangalore
KARNATAKA
560029
India 
Phone  9878940935  
Fax    
Email  charansinghgoyat@gmail.com  
 
Source of Monetary or Material Support  
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY 
 
Primary Sponsor  
Name  KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY 
Address  Dr. M.H. MARIGOWDA ROAD, BANGALORE -560029 
Type of Sponsor  Government medical college 
 
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 
CHARAN SINGH  KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY  ROOM NO 5 AND ROOM NO 74, 4th floor, DEPARTMENT OF SURGICAL ONCOLOGY, MEDICAL ONCOLOGY AND RADIATION THERAPY, OPD BLOCK, INFOSYS BUILDING
Bangalore
KARNATAKA 		 9878940935

charansinghgoyat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY MEDICAL 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, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: D||Radiation Therapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  chemotherapy, radiation and surgery  • CRT group treatment protocol: All the patients in CRT group would receive neoadjuvant long course chemoradiation with capecitabine (CAP) 825 mg/m2 twice daily on the days of radiation therapy and radiation to a dose of 50.4Gy/28# or equivalents followed by surgery after 6 to 8 weeks of last day of radiation (as per principles of Total mesorectal excision ), followed by adjuvant chemotherapy for 6 months with capecitabine and oxaliplatin (CAPOX) regimen or 5-Fluorouracil, leucovorin and oxaliplatin (mFOLFOX 6) regimen shall be started within 8 weeks of surgery. Capecitabine 1000 mg/m2 orally twice daily on days 1–14, oxaliplatin 130 mg/m2 intravenously on day 1, and a chemotherapy-free interval between days 15–21 in CAPOX regimen or oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin [folinic acid] 400 mg/m2 intravenously on days 1 and 2, followed by bolus 5-fluorouracil 400 mg/m2 intravenously and 5-fluorouracil 2400 mg/m2 intravenously infusion over 46 hours on days 1 and 2, and a chemotherapy-free interval between days 3–14 in mFOLFOX 6 regimen. • TNT group protocol: All the patients in TNT group would receive neoadjuvant short course radiotherapy (SCRT) of 25Gy/5# over a maximum period of 8 days followed by 6 months of chemotherapy will be started not more than 4 weeks after last day of radiation as CAPOX regimen or mFOLFOX 6 regimen. Surgery will be done after 2 to 4 weeks of last dose of chemotherapy (as per principles of Total Mesorectal Excision).  
Comparator Agent  radiation, chemotherapy and surgery  • CRT group treatment protocol: All the patients in CRT group would receive neoadjuvant long course chemoradiation with capecitabine (CAP) 825 mg/m2 twice daily on the days of radiation therapy and radiation to a dose of 50.4Gy/28# or equivalents followed by surgery after 6 to 8 weeks of last day of radiation (as per principles of Total mesorectal excision ), followed by adjuvant chemotherapy for 6 months with capecitabine and oxaliplatin (CAPOX) regimen or 5-Fluorouracil, leucovorin and oxaliplatin (mFOLFOX 6) regimen shall be started within 8 weeks of surgery. Capecitabine 1000 mg/m2 orally twice daily on days 1–14, oxaliplatin 130 mg/m2 intravenously on day 1, and a chemotherapy-free interval between days 15–21 in CAPOX regimen or oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin [folinic acid] 400 mg/m2 intravenously on days 1 and 2, followed by bolus 5-fluorouracil 400 mg/m2 intravenously and 5-fluorouracil 2400 mg/m2 intravenously infusion over 46 hours on days 1 and 2, and a chemotherapy-free interval between days 3–14 in mFOLFOX 6 regimen. • TNT group protocol: All the patients in TNT group would receive neoadjuvant short course radiotherapy (SCRT) of 25Gy/5# over a maximum period of 8 days followed by 6 months of chemotherapy will be started not more than 4 weeks after last day of radiation as CAPOX regimen or mFOLFOX 6 regimen. Surgery will be done after 2 to 4 weeks of last dose of chemotherapy (as per principles of Total Mesorectal Excision) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age between 18 to 75 years
2. Newly diagnosed locally advanced primary resectable rectal adenocarcinoma on biopsy without distant metastases
3. Lower border of tumour ≤ 15 cm from Anal Verge
4. High risk features on MRI: any one of below
T3 anyN M0, T4 any N M0, anyT N1+ M0, Threatened CRM, MRF involvement, Extramural vascular invasion
5. Eastern Cooperative Oncology Group (ECOG) performance score of 0–2
6. Written informed consent 
 
ExclusionCriteria 
Details  1. Extensive tumor growth leading to primarily unresectable eg. Tumor involving lumbosacral nerve root, tumor involving lateral pelvic wall, tumor involving sacrum S3 and above
2. Recurrent rectal cancer
3. Partially treated patients
4. FAP or HNPCC, Active Crohn’s disease or ulcerative colitis
5. Concomitant malignancy
6. History of peripheral neuropathy
7. History of Cardiac disease / Stroke
8. Chronic kidney disease
9. Chronic liver disease with bilirubin more than 2 mg/dl
10. Pregnant or breast-feeding women 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Pathological response in resected specimen: pCR, R0, R1  post recruitment of study patients with completion of treatment, all patients will analyzed for primary outcome. 
 
Secondary Outcome  
Outcome  TimePoints 
• Disease free survival (DFS) and overall survival (OS)
• Effect of neoadjuvant treatment: Efficacy and safety, tolerability and toxicity, compliance and Completion of scheduled treatment
• Radiological response before Surgery
• Perioperative complications
• Stoma reversal rate at 3 months post-surgery
 		 post 3 years of completion of recruitment and treatment of last patient. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 4 
Date of First Enrollment (India)   10/09/2022 
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)  Not Yet Recruiting 
Publication Details   study not completed 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

NEED FOR STUDY: As per GLOBOCAN 2018 data, colorectal carcinoma (CRC) is the third most commonly diagnosed cancer in the world comprising about 10.1 % of all new cancer diagnoses as per the registry and second in mortality (9.2%) lagging only to lung caner1. Rectal cancer alone constitutes about 40% of cases of CRC. Rectal cancer treatment remains challenging not only for clinicians but also for patients. Most of cases in rectal cancer are diagnosed in locally advanced stages in developing countries. For locally advanced rectal cancer (LARC) patients, multimodal treatment consisting of neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision (TME) surgery and adjuvant chemotherapy has become the standard of care2. As per Gollins et al, Five years local recurrence rate has reduced from more than 25% to about 5-10% due to improved surgical and neoadjuvant treatment but distant metastatic recurrence still remains around 30%, which remains the leading cause of cancer-related mortality3. The standard treatment models have also resulted in tumor downstaging, and improved quality of life but pathological complete response (pCR) is seen in 10-30% of patients only4. In a German phase 3 trial, Adjuvant chemotherapy following conventional long course chemoradiotherapy (CRT) has poor tolerability and less than 50 to 60 % of patients came for adjuvant treatment out of that only 40% complete the scheduled treatment5,6. A novel therapeutic approach, total neoadjuvant therapy (TNT) had tried to overcome such problems. This new treatment strategy is used to deliver both radiotherapy and systemic chemotherapy prior to surgery. In UNICANCER-PRODIGE 23 phase 3 trial, The compliance with TNT is more than 90% and most of the patients received the scheduled treatment without higher toxicities compared to CRT7. pCR rates with TNT are higher (20-40% when compared with CRT (10-20%). Here, we are proposing this study in cases of advanced rectal carcinoma for comparing perioperative complications and pathological outcomes in two groups.
 
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