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IRCT2014053113736N1 IRCT 2014-06-02 Tabriz University of Medical Sciences Neoadjuvant chemotherapy in gastric adenocarcinoma The effect of neoadjuvant chemotherapy on increasing resectability in patients with locally-advanced gastric cancer 2012-08-22 anticipated 60 Complete https://irct.ir/trial/13512 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Gastric adenocarcinoma. Intervention 1: Control group: Surgical exploration without neoadjuvant chemotherapy. Intervention 2: Intervention Group Neoadjuvant chemotherapy: - docetaxel 75 mg/m2, IV, 1 hour infusion, day 1 - cisplatin 75 mg/m2, IV , 2hour infusion, day 1 - 5 FU 750 mg/m2/day, IV continuous infusion, days 1-5 Will be repeat every 3 weeks for 6 courses Surgical exploration 6 weeks after the last course of chemotherapy.
public Dr. Shahriyar Hashemzadeh
Imam Reza Hospital, Golgasht St.
Tabriz Iran (Islamic Republic of) 51664 +98 41 1334 1317 shahriar_90@yahoo.com Tabriz University of Medical Sciences scientific Dr. Shahriyar Hashemzadeh
Imam Reza Hospital, Golgasht St.
Tabriz Iran (Islamic Republic of) 51664 +98 41 1334 1317 shahriar_90@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1) Age between 18-70 years old 2) Confirmation of gastric adenocarcinoma by endoscopic sampling and histopathological analysis 3) Confirmation of locally-advanced disease by preoperative computed tomography 4) Confirmation of resectability by preoperative computed tomography Exclusion criteria: 1) Ages older than 70 2) Gastric malignancies other than adenocarcinoma 3) Distant metastasis in preoperative assessment 4) Any contraindication to chemotherapy 5) History of previous chemotherapy 6) History of previous radiotherapy 18 years 70 years Both C16 Malignant neoplasm of stomach Treatment - Surgery Treatment - Drugs Control group: Surgical exploration without neoadjuvant chemotherapy Intervention Group Neoadjuvant chemotherapy: - docetaxel 75 mg/m2, IV, 1 hour infusion, day 1 - cisplatin 75 mg/m2, IV , 2hour infusion, day 1 - 5 FU 750 mg/m2/day, IV continuous infusion, days 1-5 Will be repeat every 3 weeks for 6 courses Surgical exploration 6 weeks after the last course of chemotherapy Reseactability. Timepoint: Intraoperative (After chemotherapy in case group and after diagnosis in control group). Method of measurement: Intraoperative findings. Local lymph node regression. Timepoint: After neoadjuvant chemotherapy (6 weeks). Method of measurement: Computed tomography. Tabriz University of Medical Sciences Approved 2012-06-19 Tabriz University of Medical Sciences Golgasht St. Tabriz University Tabriz Iran (Islamic Republic of)