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IRCT20211211053356N1 IRCT 2022-01-21 Shiraz University of Medical Sciences Total neoadjuvant multidrug chemotherapy in the management of gastric cancer The effect of total neoadjuvant multidrug chemotherapy including fluorouracil, leucovorin, oxaliplatin and docetaxel on pathologic complete response resectable locally advanced gastric adenocarcinoma 2022-01-21 anticipated 63 Complete https://irct.ir/trial/60735 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Gastric cancer. Intervention group: In total neoadjuvant chemotherapy group, patients will be treated with eight sessions of fluorouracil, leucovorin, oxaliplatin, and docetaxel before surgery. Fluorouracil as a 24-hour intravenous infusion at a dose of 2600 mg per body surface area on the first day, leucovorin as a 1-hour intravenous infusion at a dose of 200 mg per body surface area on the first day, oxaliplatin as a 1-hour intravenous infusion at a dose of 85 mg per body surface area on the first day and docetaxel as a 2-hour intravenous infusion at a dose of 50 mg per body surface area on the first day will be administered. Chemotherapy will be performed every 2 weeks in 8 sessions.. Yes - There is a plan to make this available What will be shared: After the consent of the scientific officer and the approval of the ethics committee, all data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Study data will be available only to researchers working in academic and scientific institutions. Conditions: The results of this study can be used for pooled meta-analysis. Where to obtain: The data can be accessed by correspondence with the scientific officer. Address: Radiation Oncology ward, Nemazee Teaching Hospital, Namazi Sq., Zand Ave. Shiraz, Fars. 7134814336. Iran Phone +98 71 3647 4332 Cellphone +98 921 165 5956 Fax +98 71 3647 4326 E-mail address mehrdadg239@gmail.com How to obtain: After the consent of the scientific officer and the approval of the ethics committee, all data is potentially shareable after unidentified individuals Comments:
public Mehrdad Golmoradi
Radiation Oncology ward, Nemazee Teaching Hospital, Namazi Sq., Zand Ave.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3647 4332 mehrdadg239@gmail.com Shiraz University of Medical Sciences scientific Mehrdad Golmoradi
Radiation Oncology ward, Nemazee Teaching Hospital, Namazi Sq., Zand Ave.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3647 4332 mehrdadg239@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Pathologically confirmed gastric adenocarcinoma in biopsy Perigastric lymph node metastasis in CT scan Resectable primary gastric tumor based on CT scan 18 years 70 years Both Presence of distant metastasis at the presentation Previous history of chemotherapy Previous history of radiotherapy Previous history of malignancy Suffering from uncontrolled diabetes mellitus Suffering from uncontrolled hypertension No consent to enroll C16.9 Malignant neoplasm of stomach, unspecified Treatment - Drugs Intervention group: In total neoadjuvant chemotherapy group, patients will be treated with eight sessions of fluorouracil, leucovorin, oxaliplatin, and docetaxel before surgery. Fluorouracil as a 24-hour intravenous infusion at a dose of 2600 mg per body surface area on the first day, leucovorin as a 1-hour intravenous infusion at a dose of 200 mg per body surface area on the first day, oxaliplatin as a 1-hour intravenous infusion at a dose of 85 mg per body surface area on the first day and docetaxel as a 2-hour intravenous infusion at a dose of 50 mg per body surface area on the first day will be administered. Chemotherapy will be performed every 2 weeks in 8 sessions. Pathologic response. Timepoint: After the intervention and providing the pathologic report of gastrectomy. Method of measurement: Based on report of pathologist. Surgical margin status. Timepoint: After the intervention and providing the pathologic report of gastrectomy. Method of measurement: Based on pathologist report. Treatment completion rate. Timepoint: During the intervention, every three week. Method of measurement: History taking. Treatment toxicity. Timepoint: During the intervention, every three week. Method of measurement: history taking. Shiraz University of Medical Sciences Approved 2021-08-19 Research Ethics Committees of School of Medicine - Shiraz University of Medical Sciences Zand St., Imam Hossein Sq., Shiraz Medical School Shiraz Fars Iran (Islamic Republic of)