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CTRI Number  CTRI/2021/01/030370 [Registered on: 11/01/2021] Trial Registered Prospectively
Last Modified On: 16/02/2026
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 study to compare the usefulness of two types of treatment in avoiding surgery in people with rectal cancer. 
Scientific Title of Study
Modification(s)  
SOCCER: a phase two randomised trial comparing complete clinical response after Short course radiation Or Chemoradiation and Consolidation chEmotherapy in Rectal cancer 
Trial Acronym  SOCCER 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramakrishnan Ayloor Seshadri 
Designation  Professor of Surgical Oncology 
Affiliation  Cancer Institute (WIA) 
Address  Dept. of Surgical Oncology, Cancer Institute (WIA), Dr.S.Krishnamurthy campus, No.38, Sardar Patel road, Chennai

Chennai
TAMIL NADU
600036
India 
Phone  09840085569  
Fax    
Email  ram_a_s@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramakrishnan Ayloor Seshadri 
Designation  Professor of Surgical Oncology 
Affiliation  Cancer Institute (WIA) 
Address  Dept. of Surgical Oncology, Cancer Institute (WIA), Dr.S.Krishnamurthy campus, No.38, Sardar Patel road, Chennai

Chennai
TAMIL NADU
600036
India 
Phone  09840085569  
Fax    
Email  ram_a_s@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Ramakrishnan Ayloor Seshadri 
Designation  Professor of Surgical Oncology 
Affiliation  Cancer Institute (WIA) 
Address  Dept. of Surgical Oncology, Cancer Institute (WIA), Dr.S.Krishnamurthy campus, No.38, Sardar Patel road, Chennai

Chennai
TAMIL NADU
600036
India 
Phone  09840085569  
Fax    
Email  ram_a_s@yahoo.com  
 
Source of Monetary or Material Support  
Cancer Institute WIA Dr. S. Krishnamurthy campus, No.38, Sardar Patel road, Chennai-600036 
 
Primary Sponsor  
Name  Cancer Institute WIA 
Address  Dr. S. Krishnamurthy campus, No.38, Sardar Patel road, Chennai-600036 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ramakrishnan A S  Cancer Institute (WIA)  Dept. of Surgical Oncology 3rd Floor Bhagwan Adinath Jain Complex Dr.S.Krishnamurthy campus, No.38, Sardar Patel road, Chennai-600036
Chennai
TAMIL NADU 
09840085569

ram_a_s@yahoo.com 
DrAnuradha Chandramohan  Christian Medical College  Dept of Radiology IDA Scudder Road Vellore-632004
Vellore
TAMIL NADU 
09443449726

anuradhachandramohan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D||Radiation Therapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Long course chemoradiation followed by consolidation chemotherapy  Patient will receive 54 Gy external beam radiation along with Capecitabine (oral 825 mg/m2 twice daily) over a period of 6 weeks followed by 6 three weekly cycles of chemotherapy containing Capecitabine(825 mg/m2 twice daily) and Oxaliplatin(IV). In case of a complete or near complete response the patient will be placed on a non-operative management program. In case of an incomplete response the patient will undergo immediate surgery. 
Comparator Agent  Short course radiation followed by consolidation chemotherapy  Patient will receive 25 Gy external beam radiation (5 Gy x 5 days) followed by 6 three weekly cycles of chemotherapy containing Capecitabine(825 mg/m2 twice daily) and Oxaliplatin(IV). In case of a complete or near complete response the patient will be placed on a non-operative management program. In case of an incomplete response the patient will undergo immediate surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients must fulfil all of the following criteria to be considered eligible:
1. Histologically confirmed adenocarcinoma of the rectum 0-8 cm from anal verge
2. Age 18-70 years
3. ECOG performance status 0-2
4. MRI staged LARC deemed to require neoadjuvant radiation- Stage II (T3, N0) or Stage III (T1-3, N1-3)
5. Potentially resectable (amenable to total mesorectal excision)
6. No prior treatment for rectal cancer (chemotherapy or surgery or radiation)
7. Absolute neutrophil count > 1.5 cell/mm3, Hemoglobin>8.0 gm/ dL, Platelets> 150,000/mm3, total bilirubin ≤ 1.5 x upper limit of normal, AST ≤upper limit of normal, ALT≤ three times upper limit of normal, serum creatinine≤ 1.5 x upper limit of normal
9. Must have signed an informed consent form to participate in the study
 
 
ExclusionCriteria 
Details  Patients will not be eligible if they fulfil any of the following:
1. Presence of distant metastasis
2. Recurrent rectal cancer
3. Symptomatic bowel obstruction due to the tumor
4. Mucinous tumors or signet ring cell carcinoma
5. Familial adenomatous polyposis or hereditary non polyposis colorectal cancer
6. Have a contraindication for MRI e.g. non-MR compatible hip prosthesis, cardiac pacemaker
7. Patients who have received prior pelvic radiotherapy or have a contraindication to radiation
8. Patients who have any contraindication or hypersensitivity to the systemic chemo agents used in this study including but not limited to neuropathy, known DPD deficiency.
9. History of thrombotic arterial events eg. stroke, myocardial infarction in the last 12 months or clinically significant cardiac disease or left ventricular ejection fraction <50%
10. Patients with any other concurrent uncontrolled medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study according to the investigator’s judgement.
11. Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
12. Patients receiving other anticancer or experimental therapy.
13. Patients who are pregnant, breastfeeding
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Difference in the proportion of complete or near complete responses- (near) cCR- in the two treatment arms   24 weeks from completion of (chemo) radiation 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Difference between the Organ preservation rates in the two arms  2 years from date of response assessment 
Proportion of local regrowths in patients on NOM pathway  2 years from date of response assessment 
Disease-free survival of patients in the NOM pathway   2 years from date of response assessment 
Difference between the two arms in the frequency of Grade 3 or more adverse events   During treatment- After completion of radiation & after each cycle of chemotherapy
In patients on NOM pathway- at 12 & 24 months from response assessment. 
Difference in the compliance to consolidation chemotherapy between the two arms   From beginning of neoadjuvant treatment upto completion of (chemo) radiation. 
Diagnostic performance of the pre-defined criteria for cCR and near cCR.   From response assessment to 12 months from decision for NOM]. 
Difference between the two arms in the proportion of Grade 3 or more 30-day surgical complication measured by the Clavien-Dindo score   From day of surgery till 30 days post-operative  
Difference in the Health related quality of life- assessed by EORTC CR29 & CR30
between patients in the NOM pathway & those undergoing TME 
Time frame from randomisation till 2 years from response assessment 
Difference between patients in the NOM pathway & those undergoing TME in bowel
function [ 
From randomisation till 2 years from response assessment 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   15/01/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The primary objective of this study is to compare the organ preservation potential of two neoadjuvant regimens (an escalated dose chemoradiation regimen or short course radiation followed by consolidation chemotherapy) in patients with LARC. Neoadjuvant chemoradiation followed by radical surgery is the standard practice for locally advanced low rectal cancer. However, surgery often leads to formation of a temporary or permanent stoma and is also associated with short term complications and long term bowel, sexual and urinary dysfunction leading to an impaired quality of life. In a recent trial by the investigators, nearly 15% patients refused surgery after neoadjuvant treatment. Total neoadjuvant therapy is increasingly being used in rectal cancer management and increases the tumor response rates. Patients who have a complete response to neoadjuvant treatment have an excellent long term outcome. Although a complete clinical response is not always concordant with a complete pathological response, there is growing interest in a non-operative management of patients who achieve a complete clinical response. The good oncological outcome of this approach is supported by evidence from meta-analyses and publications from a large international registry. It has also been reported that patients who achieve a complete clinical response express a strong preference to avoid surgery and are willing to trade life expectancy for improvements in quality of life. Current organ preserving studies are focusing on an aggressive neoadjuvant long course chemoradiation regimen with consolidation chemotherapy which has shown good results. Short course radiation followed by consolidation chemotherapy is also recommended in locally advanced rectal cancer but its role in organ preservation has not been studied. Hence we intend to compare the organ preserving potential of these two promising regimens in a prospective clinical trial.

 
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