Locally advanced adenocarcinoma of the esophago gastric junction and proxmimal of the stomach. Malignant neoplasm of cardia
Conditions
Interventions
Intervention group: In the intervention group, before neoadjuvant chemoradiotherapy, patients will undergo two cycles of chemotherapy with FLOT regimen (containing fluorouracil, leucovorin, oxaliplati
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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 ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Resection of malignant lesion during surgery. Timepoint: Post surgery based on pathologic report. Method of measurement: ?ased 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Amir Aledavood
Mashhad University of Medical Sciences
Outcome results
None listed