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CTRI Number  CTRI/2026/01/100455 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Radiation Therapy
Other (Specify) [chemoradiotherapy]  
Study Design  Single Arm Study 
Public Title of Study   The Role of Preoperative Chemoradiotherapy in turning Inoperable Stomach cancer into Operable in a Pilot Study 
Scientific Title of Study   The Effect of Preoperative Chemoradiotherapy on Resectability for Locally Advanced ,Unresectable Gastric cancer-A Pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashmita Rijal 
Designation  Junior Resident, Post graduate [ General Surgery junior resident] 
Affiliation   
Address  JIPMER, PONDICHERRY JIPMER Campus road , Gorimedu ,Dhanvantari Nagar, Puducherry, 605006 Department of General Surgery JIPMER Email:ashmita2491@gmail.com Harvey hostel complex room no 306 , JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  8427032491  
Fax    
Email  ashmita1171@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anandhi A 
Designation  Additional Professor [ Department Of General Surgery] 
Affiliation  JIPMER 
Address  JIPMER, PONDICHERRY JIPMER Campus road , Gorimedu ,Dhanvantari Nagar, Puducherry, 605006 Block, JIPMER, for other queries / Complaints , contact member Secretary , Room no 106 , IEC [Human studies], Dean Research Office, First floor , Administrative

Pondicherry
PONDICHERRY
605006
India 
Phone  9487781661  
Fax    
Email  anandhiramesh76@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Anandhi A 
Designation  Additional Professor [ department of General Surgery] 
Affiliation  JIPMER 
Address  JIPMER, PONDICHERRY JIPMER Campus road , Gorimedu ,Dhanvantari Nagar, Puducherry, 605006 Block, JIPMER, for other queries / Complaints , contact member Secretary , Room no 106 , IEC [Human studies], Dean Research Office, First floor , Administrative

Pondicherry
PONDICHERRY
605006
India 
Phone  9487781661  
Fax    
Email  anandhiramesh76@yahoo.in  
 
Source of Monetary or Material Support  
JIPMER, JIPMER campus road, Gorimedu , Dhanvantri Nagar , Puducherry 605006 Pondicherry [No Monetory support, Patient will be recruited from the General Suregy /Medical oncology department of JIPMER institute] Block, JIPMER, for other queries / Complaints , contact member Secretary , Room no 106 , IEC [Human studies], Dean Research Office, First floor , Administrative  
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER, PONDICHERRY 
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 Ashmita Rijal  JIPMER  JIPMER, PONDICHERRY Department of Surgery Room no 86, OPD block and ward 36 ,34,37 IPD block JIPMER Campus road , Gorimedu ,Dhanvantari Nagar, Puducherry, 605006 Pondicherry India
Pondicherry
PONDICHERRY 		 8427032491

ashmita1171@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Interventional Studies JIPMER, Puducherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C162||Malignant neoplasm of body of stomach, (2) ICD-10 Condition: C160||Malignant neoplasm of cardia, (3) ICD-10 Condition: C161||Malignant neoplasm of fundus of stomach, (4) ICD-10 Condition: C163||Malignant neoplasm of pyloric antrum, (5) ICD-10 Condition: C164||Malignant neoplasm of pylorus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chemoradiotherapy will be given pre surgery followed by chemotherapy post surgery , when patient is eligible for the curative intent palliative intent the chemotherapy will be continued  Chemotherapy with FLOT or CAPOX 3 cycles each in peroperative and postoperative/ palliative time flurouracil 2600mg per square meter, administered intravenously on day 1, leucovorin 200mg per square meter , administered on day 1, oxaliplatin 85 mg per square meter on day 1and docetaxel 50mg per square meter on day 1 and Radiotherapy in preoperative time only with 45 gy administered in 25 fractions, 5 days per week for 5 weeks  
Comparator Agent  nil , no comparator arm since its a single arm study  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Histologically confirmed Adenocarcinoma, of the stomach or gastroesophageal junction [steiwert3], Stage 4b[Invasion of Adjacent structures] or bulky N2/N3 disease deemed inoperable by multidisplinary team[MDT] after staging with CECT or Pec-ct and D-laparoscopy.(inoperability criteria - involvement of adjacent organs like pancreas, liver, spleen etc, lesion encroaching duodenum, non regional lymph nodes like paraaortic nodes, involvement of bile duct, involvement of bile duct, common hepatic artery, celiac trunk
2.Age 18 to 70
3.ECOG 0-1 
 
ExclusionCriteria 
Details  1.Disease metastasis [M1]
2.Prior Chemotherapy or Radiotherapy for gastric cancer
3.Uncontrolled comorbidites [ cardiac ejection fraction less than 50 percent, severe COPD,s. Creatinine more than 1.6mg/dl]
4.Pregnancy or Breast Feeding
5.Contraindication to radiotherapy [prior abdominal radiation, connective tissue disorder] 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To asses the R0 [complete microscopic resection ]resection rate in patient with unresectable locally advanced gastric cancer in the setting of preoperative chemoradiotherapy
[This will be check on the histopathology specimen retrieve post surgery] 		 This will be checked postoperatively by histopathology within some 1-2 week of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the Radiologiocal [after CTRT ] & pathological tumor response rate [post surgery]
 		 via RESCIST criteria within 2-3 weeks of preoperative chemoradiotherapy
& Histopathological examination with 1-2 weeks of surgery respectively
within  
2. To assess treatment compliance & toxicity profile   Patient will be assessed in weekly basis in OPD as they come of the next cycle & after completion of Chemotherapy & radiotherapy respectively in the respective OPD & in Surgery OPD in 4 weeks time period & will also be told to come in emergency if severe toxicity so developed SOS  
3.To assess event free survival, [events are local and/or regional recurrence or progression ,distant recurrence or death from any cause  it will be assessed in 6months & 1 year of respective sample collection  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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/ Phase 3 
Date of First Enrollment (India)   17/01/2026 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ashmita1171@gmail.com].

  6. For how long will this data be available start date provided 30-10-2028 and end date provided 30-10-2033?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   After obtaining ethical committee approval patient will be recruited according to the eligibility criteria and obtaining informed consent, To Assess the eligibility patient will undergo CECT-TAP and Diagnostic Laparoscopy to assess TNM staging and resectability , and found to be Locally advanced unresectable with no obvious metastasis will be included in study. 
Patient will receive 3 cycles of preoperative FLOT or CAPOX followed by chemoradiotherapy and then same postoperative chemotherapy for 3 cycles after curative surgery . the chemoradiotherapy will be given 3-4 weeks after completion of chemotherapy. 
After 4 weeks of neoadjuvant treatment patient will be assed with CECT , RECIST criteria for tumor resp[onse will be assess , if found responsive on imaging , patient will be asses with diagnostic laparoscopy and will be planned for surgery subtotal or total gastrectomy with D2 lymphadenectomy with minimum approach of D1+ resection , post surgery patient will receive chemotherapy with FLOT or CAPOX  with curative [R0] or Palliative [R1] intent. If patient is unresectable then palliative chemotherapy will be given. 
Clinical evaluation will be done in OPD visit for every 3- month for 1 year. CECT evaluation at 6 month and 1 year  
 
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