Health Condition 1: C16- Malignant neoplasm of stomach
Conditions
Interventions
Intervention1: Neoadjuvant chemotherapy followed by surgery: Chemotherapy FLOT4x6 cycles
Control Intervention1: Surgery followed by adjuvant chemotherapy: Chemotherapy FLOT4x6 cycle
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Reserach
Eligibility
Inclusion 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 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
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 ii) Are HBsAg positive with chronic HBV infection (lasting 6 months or longer) and meet conditions below a) HBV DNA viral load b) Have normal transaminase values c) Start or maintain antiviral treatment if clinically indicated as per the investigator. 8. Patients who are unwilling or unable to follow protocol requirements 9. Active Hematemesis requiring frequent transfusion support or inotropes 10. Perforation 11. Recent CVA within two months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary End Point: 3 years EFS (Event free survival) Timepoint: EFS- Time from randomization to recurrence of the original gastric cancer, development of new gastric cancer, metastasis or death from any cause whichever has occurred first. Assessed by CECT Scan done once every 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary End Points: irEFS, DFS, OS, Ro resection rates, Chemotherapy completion rates Toxicity, QOL Timepoint: 2. 3 years Disease free survival (DFS) Disease-free survival (DFS) will be defined as the time from completion of therapy to the recurrence of the original gastric cancer, development of new gastric cancer, metastasis or death from any cause whichever has occurred first. 4. 3 years Overall survival (OS) The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation (censored). | — |
Countries
India
Contacts
Public ContactBiswajit Dubashi
JIPMER
Outcome results
None listed