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IRCT20210706051800N1 IRCT 2022-09-19 Mashhad University of Medical Sciences effect of chemotherapy befor chemoradiation on response rate FLOT induction chemotherapy before neoadjuvant chemoradiotherapy and resectability and pathologic response in patients with esophagogastric junction and Proximal gastric adenocarcinomas 2022-09-23 anticipated 40 Complete https://irct.ir/trial/57400 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Locally advanced adenocarcinoma of the esophago gastric junction and proxmimal of the stomach. Intervention group: In the intervention group, before neoadjuvant chemoradiotherapy, patients will undergo two cycles of chemotherapy with FLOT regimen (containing fluorouracil, leucovorin, oxaliplatin and docetaxel). Inpatient FLOT chemotherapy protocol with drugs oxaliplatin 85 mg/m2 over two hours in dextrose water serum on the first day, Leucovorin 200 mg/m2 over two hours in normal saline serum on the first day, docetaxel 50 mg/m2 within one hour in normal saline serum on the first day and 5 fluorouracil 2600 mg/m2 within 24 hours in normal saline serum on the first day [or if the treating physician sees fit, infusion of 1200 mg/m2 daily within 48 hours]. To perform radiotherapy, simulation based on CT scan will be used. Patients will be subjected to a CT scan of the thorax and abdomen in the supine position. The chemotherapy protocol will be simultaneous with radiotherapy in the form of paclitaxel (50 mg/m2 ) and carboplatin (AUC=2) weekly during the radiotherapy period.. No - There is not a plan to make this available Justification or reason for not sharing IPD is The need to share non-identifiable personal data of patients is not felt individually, and it is sufficient to determine the benefits of the intervention performed in all patients or a subgroup of them with special characteristics.

public Seyed Amir Aledavood

Omid Hospital, Alandasht Crossroads, Koohsangi Ave

Mashhad Iran (Islamic Republic of) 9188959986 +98 51 3842 6082 aledavooda@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Amir Aledavood

AlaNadasht Crossroads, Koohsangi Ave

Mashhad Iran (Islamic Republic of) 9188959986 +98 51 3842 6082 aledavooda@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Appropriate performance status(ECOG score0-1) Presence of pathologic diagnosis based on adenocarcinoma of the distal of esophagus and the proximal of stomach and the esophago-gastric junction Resectable malignant lesion(stageIB-IIIB) 18 years 65 years Both Presence of siginificant comorbidity included uncontrolled diabetus mellitus,uncontrolled hypertension,history of ischemic heart disease and CABG,history of cerebrovascular accident(CVA),grade 2 or more neuropathy, failure of bone marrow(lymphopenia and leukopenia and thrombocytopenia in initial review),heart failure(EF≤45%),renal dysfunction(GFR<50 mg/m),hepatic dysfunction (AST/ALT≥3×ULN و Billt≥1.5×ULN) which prevents the prescription of neoadjuvant or surgery for the patient History of collagen vascular disease Presence of metastatic disease in initial review History of previous chemotherapy or radiotherapy History of malignancy of solid organs during the last 5 years( except skin BCC/SCC and cervical CIN which were treated with surgery Advanced inoperable cancer Pregnancy and breastfeeding C16.0 Malignant neoplasm of cardia Treatment - Other Intervention group: In the intervention group, before neoadjuvant chemoradiotherapy, patients will undergo two cycles of chemotherapy with FLOT regimen (containing fluorouracil, leucovorin, oxaliplatin and docetaxel). Inpatient FLOT chemotherapy protocol with drugs oxaliplatin 85 mg/m2 over two hours in dextrose water serum on the first day, Leucovorin 200 mg/m2 over two hours in normal saline serum on the first day, docetaxel 50 mg/m2 within one hour in normal saline serum on the first day and 5 fluorouracil 2600 mg/m2 within 24 hours in normal saline serum on the first day [or if the treating physician sees fit, infusion of 1200 mg/m2 daily within 48 hours]. To perform radiotherapy, simulation based on CT scan will be used. Patients will be subjected to a CT scan of the thorax and abdomen in the supine position. The chemotherapy protocol will be simultaneous with radiotherapy in the form of paclitaxel (50 mg/m2 ) and carboplatin (AUC=2) weekly during the radiotherapy period. Resection of malignant lesion during surgery. Timepoint: Post surgery based on pathologic report. Method of measurement: إased on residual tumor classification on including R0:lack of micro and macroscopic residue R1:microscopic residue and positive surgical margin and lack of gross residue R2:gross residue. Tumor response to neoadjuvant therapy in pathology after surgery. Timepoint: Post surgery based on pathologic report. Method of measurement: Based on American Institue of pathology:1)Complete response in the sense of the absence of tumoral cells in the primary location of the tumor and lymph nodes 2)partial response: presence of limited tumor remnants with fibrosis in the primary site and examined nodes and 3)No response:presence of tumoral cells in the primary location of the tumor and lymph nodes. Complications of chemotherapy. Timepoint: During induction chemotherapy every 2 weeks and during chemoradiation weekly. Method of measurement: History,Physical exam, lab test include complete blood count and kidney function test and liver function test and complication of treatment based on Common Terminology Criteria for Adverse Events(CTCAE-EORTC). Complications of Radiotherapy. Timepoint: Weekly During Radiotherapy and then monthly. Method of measurement: Complication of treatment based on Common Terminology Criteria for Adverse Events(CTCAE-EORTC). Mashhad University of Medical Sciences Approved 2021-06-01 Ethics Committee of Mashhad University of Medical Sciences Medical Science university,Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)