CTRI/2021/01/030183招募中3 期
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 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
- •a) HBV DNA viral load < 2000 IU/ml
- •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
研究者
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