| 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
|
|
|
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
|
|
|
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. |