effect of chemotherapy befor chemoradiation on response rate

Phase 2

Recruiting

Conditions: ocally advanced adenocarcinoma of the esophago gastric junction and proxmimal of the stomach.
Malignant neoplasm of cardia
C16.0

Registration Number: IRCT20210706051800N1

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).