Clinical Trial Details (PDF Generation Date :- Tue, 09 Apr 2019 10:09:21 GMT) CTRI Number Last Modified On 18/09/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/07/004767 [Registered on: 25/07/2014] - Trial Registered Prospectively No Observational Cohort Study Other To assess response of tumor to chemotherapy given before surgery by using PET CT scan. Prediction of tumor response to neo-adjuvant therapy in adenocarcinomas of the gastroeosphageal junction (AEG) using FDG PET/CT Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) NIL NIL Details of Principal Investigator Department of Nuclear Medicine,, Dr E, Dr E Mumbai Details Contact Person (Scientific Query) Department of Nuclear Medicine,, Dr E, Dr E Details Contact Person (Public Query) Details Contact Person (Public Query) Department of Nuclear Medicine,, Dr E, Dr E page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria > Source of Monetary or Material Support Primary Sponsor Details Not applicable Type of Sponsor Other [] List of Countries of Principal Investigator of Site Site Phone/Fax/, Bio-Imaging Unit,PET-CT Dr E Borges Marg, Parel, Mumbai- Mumbai 09821468436 -- nilpurandare@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee Status Health Type Patients Approved 03/03/2014 No Date No Date Specified Condition Patients taking treatment of cancer Type Details Age From Age To Gender Details Details 18.00 Year(s) 80.00 Year(s) Both Inclusion Criteria All operated patients of esophageal adenocarcinoma who have undergone pre and post neo-adjuvant chemotherapy FDG PET/CT. Exclusion Criteria Previously operated patients Patients who have not undergone either the baseline or the post NACT PET/CT Patients who have received chemotherapy or radiation therapy prior to the initial PET/CT. Patients who are operated without receiving NACT. Method of Generating Random Sequence page 2 / 5
Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints Primary objective 1) To evaluate the ability of FDG PET/CT in predicting histopathological response after neo-adjuvant chemotherapy in patients with adenocarcinoma of the gastroesophageal junction. 2 years Secondary Outcome Outcome Timepoints 1.To assess if reduction in metabolism on FDG PET predict disease free survival (DFS) 2. To compare morphological response with histopathological response. 2 years Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Total Sample Size=75 Sample Size from =75 N/A 01/08/2014 No Date Specified Years=2 Months=0 Days=0 Completed Brief Summary Patients : Will be Published in Index Journal The study will include all operated patients of esophageal adenocarcinoma who have undergone pre and post neo-adjuvant chemotherapy FDG PET/CT studies from October 2010 to Jan 2013 Routine investigations for diagnosis and staging will be performed in all patients. Investigations done will include upper gastrointestinal endoscopy and biopsy, PET-CECT and EUS. PET/CT findings and histological findings will be entered into a database. Metabolic response using FDG PET and histopathological response will be calculated as follows : Metabolic Response Baseline/pre treatment FDG PET/CT study will be used to obtain the SUVmax of the lesion-(suv1). FDG PET/CT performed after 3 cycles of neo-adjuvant chemotherapy will be used to obtain (SUV2) of the lesion. page 3 / 5
Metabolic response will be calculated as percentage reduction of SUV max (Reduction rate/delta SUV %) by the formula- SUV2-SUV1/SUV1x100. To identify an optimal threshold value of percentage Delta-SUV (reduction rate)capable of separating patients who had an optimal pathologic response (pr) and patients who had a pathologic nonresponse (pnr), a receiver operating characteristic (ROC) analysis will be performed. Reduction of metabolic tumor volume (MTV) and total lesion glycolysis (TLG) will also be calculated using commercially available software. HistopathPatients : The study will include all operated patients of esophageal adenocarcinoma who have undergone pre and post neo-adjuvant chemotherapy FDG PET/CT studies from October 2010 to Jan 2013 Routine investigations for diagnosis and staging will be performed in all patients. Investigations done will include upper gastrointestinal endoscopy and biopsy, PET-CECT and EUS. PET/CT findings and histological findings will be entered into a database. Metabolic response using FDG PET and histopathological response will be calculated as follows : Metabolic Response Baseline/pre treatment FDG PET/CT study will be used to obtain the SUVmax of the lesion-(suv1). FDG PET/CT performed after 3 cycles of neo-adjuvant chemotherapy will be used to obtain (SUV2) of the lesion. Metabolic response will be calculated as percentage reduction of SUV max (Reduction rate/delta SUV %) by the formula- SUV2-SUV1/SUV1x100. To identify an optimal threshold value of percentage Delta-SUV (reduction rate)capable of separating patients who had an optimal pathologic response (pr) and patients who had a pathologic nonresponse (pnr), a receiver operating characteristic (ROC) analysis will be performed. Reduction of metabolic tumor volume (MTV) and total lesion glycolysis (TLG) will also be calculated using commercially available software. Histopathological Response Histopathological response will be calculated using tumor regression grade (TRG) TRG Grades 1 & 2 will be grouped as histomorphological responders. page 4 / 5
Powered by TCPDF (www.tcpdf.org) TRG Grades 3, 4 & 5 will be grouped as non-responders.ological Response Histopathological response will be calculated using tumor regression grade (TRG) TRG Grades 1 & 2 will be grouped as histomorphological responders. TRG Grades 3, 4 & 5 will be grouped as non-responders. page 5 / 5