A randomised, phase III study of adjuvant platinum/docetaxel with or without radiotherapy in resected locally advanced gastric cancer. Evaluation of prognostic value of molecular markers.

Hellenic Cooperative Oncology Group0 个研究点目标入组 206 人开始时间: 2009年9月1日最近更新: 2020年1月13日

研究概览

暂无简介。

•Histologicaly confirmed gastric adenocarcinoma (gastroesophageal junction included).
•Radical excision of the tumor: complete resection of (macroscopically) visible tumor, clear resection margins, no evidence of disease in the peritoneum or in other organs. Patients with limited infiltration of adjacent organs (lesser omentum, pancreas, mesocolon) will be eligible for the study provided that the (macroscopically) visible disease has been resected and the resection margins are clear.
•Infiltration of at least the serosa [T3 according to American Joint Committee on Cancer (AJCC)] or evidence of infiltrated lymphnodes.
•Age > 18 years
•Absence of heart failure
•Absolute Neutrophil Count (ANC)>1.500, platelets (PLT)>100.000, serum bilirubin within the normal range, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2xN, creatinine clearance >60 ml/min (calculation according to Cockroft Formula is accepted in patients with normal serum creatinine. Otherwise, 24h urine collection or Glomerular filtration rate (GFR) is required).
•Performance Status (PS)< 2
•Sufficient nutrition: increased body weight compared with the weight prior to gastrectomy or intake of > 1500 kcal

•Previous history of other malignancy except for completely resected basal cell or squamous skin carcinoma.
•Previous history of chemotherapy or radiotherapy
•Pregnant or lactating women, or patients unwilling to follow adequate contraceptive methods during treatment period.
•Any concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psyciatric disorder that would interfere with the subject safety.

发起方

Hellenic Cooperative Oncology Group