CTRI/2021/01/030183
Recruiting
Phase 3
eoadjuvant chemotherapy followed by Surgery versus Surgery followed by adjuvant chemotherapy for resectable Gastric adenocarcinoma – Phase 3 – Multicentric Randomized Controlled trial - NAGA
Jawaharlal Institute of Postgraduate Medical Education and Reserach0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C16- Malignant neoplasm of stomach
- Sponsor
- Jawaharlal Institute of Postgraduate Medical Education and Reserach
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \=18 years and \=70 years (female and male)
- •2\. Newly diagnosed Histologically proven adenocarcinoma of Gastric and Gastro esophageal region (Seiwerts Type 3\)
- •3\. c ( \>T1\) and or node positive (N\+)with no evidence of distant metastasis (AJCC 8th edn) as evaluated by CECT abdomen \&Pelvis and staging laparoscopy
- •4\. Eastern Cooperative Oncology Group (ECOG) performance status 0 \-1
- •5\.Left Ventricular Ejection fraction (LVEF) \= 50% as per Echocardiography (ECHO).
- •6\. Female patients with child\-bearing potential should undergo pregnancy test (serum b\-hcg) within 7 days of randomization. She should be willing to follow appropriate contraception methods during the study period.
- •7\.Patient with adequate bone marrow, renal and hepatic function. Bone marrow function ANC \> 1500/mm3, Platelet count \> 100,000/mm3, Hemoglobin \= 8 gm/dl, Renal function Serum creatinine \< 1\.5 times ULN, Hepatic function Bilirubin \< ULN, ALT/AST \< 1\.5 times ULN \& Alkaline phosphatase \< 2\.5 times ULN
- •8\.. Patients presenting with gastric outlet obstruction (GOO) should be hemodynamically stable with appropriate feeding procedure in place like NJ tube/ Feeding jejunostomy / gastro jejunostomy
Exclusion Criteria
- •1\. Gastroesophageal carcinoma ( Seiwerts Type 1\&2\)
- •2\. Previous cytotoxic chemotherapy or radiotherapy
- •3\. Unresectability as defined by contrast enhanced CT scan of the abdomen and Pelvis.
- •4\. Any of the following cardiac conditions: a. Unstable angina ,b. Myocardial infarction within the past 6 months, c. Severe uncontrolled ventricular arrhythmias, d. Clinically significant pericardial disease, e. Electrocardiographic evidence of acute ischemia, f. Patient with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable for the past six months 6, g. History of cardiac disease that met the NYHA Classification class 2 or greater
- •5\. Peripheral polyneuropathy \>NCI GradeII
- •6\. Uncontrolled diabetes or infection.
- •7\. Known case of HIV infection/ Hepatitis B/ Hepatitis C,
- •Has active or uncontrolled hepatitis B or C virus infection – participants eligible if they:
- •i) Have been curatively treated for hepatitis C virus (HCV) infection as demonstrated clinically
- •and by viral serologies
Outcomes
Primary Outcomes
Not specified
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