esophageal cancer. Malignant neoplasm of esophagus
Conditions
Interventions
Intervention 1: Intervention group: Receiving the mFOLFOX7 chemotherapy regimen during radiotherapy. In this group, patients undergo radiation therapy (RT) with a dose of 41.4 Gy in 23 sessions (1.8 G
3 times every 2 weeks on days 1, 15 and 29 including: Oxaliplatin with a dose of 270 mg/m2 in people over 60 years old and a dose of 85 mg/m2 in people under 60 years old
injection on day 1, 5-fluorouracil (FU) as an infusion at a dose of 2400 mg/m2 over two days through a port-connected infusion pump
injection on the first day, leucovorin (LV) with a dose of 400 mg/m2
injection on the first day, pembrolizumab with a dose of 200 mg
Two injections, two weeks after the end of CRT, three weeks apart. Intervention 2: Control group: Receiving the CP chemotherapy regimen during radiotherapy. In this group, patients undergo radiation
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ECOG Functional Status 0 & 1 EUS and PET/CT for local staging and evaluation of locoregional staging and distant metastasis Adenocarcinoma or SCC of middle and lower thoracic esophagus including GEJ with Sivert 1 and 2 (from 25 cm from the incisor to the end of the cardia) T1N1-3M0 or T2-4N0-3M0 cancer stages based on EUS and PET/CT. All affected areas (tumor and lymph nodes) in all patients should be operable (surgically respectable) and placed in radiotherapy fields. The maximum length of the tumor is 10 cm Proper liver, renal and blood function as follows: ? Number of granulocytes = 1500 per µl ? Platelet count = 100,000 per µl ? Bilirubin = 1.5 times the maximum normal value (ULN) ? Liver enzymes AST and ALT = 2.5 times the maximum normal value ? Creatinine clearance = 60 (according to Cockcroft and Gault formula) Men and women of childbearing age should use sperm and ovum preservation techniques before starting treatment. Sexually active women of childbearing age should use contraceptives during treatment. Obtaining Informed Consent
Exclusion criteria
Exclusion criteria: Primary tumor in the cervical and upper thoracic esophagus (15 to 25 cm from the anterior tooth according to the endoscopic report) Presence of distant metastasis on initial CT or PET Stage T4b or tracheobronchial fistula on EUS The presence of a supraclavicular pathological lymph node while the primary tumor is located in the middle or lower esophagus. Pathology of SCC with celiac node involvement Positive cytology in diagnostic laparoscopy Adenocarcinoma pathology with dMMR reporting The presence of a stent in the esophagus History of chemotherapy or radiation therapy ofthe mediastinum and upper abdomen The existence of contraindications for receiving 5-fluorouracil, taxane and platinum drugs Pregnancy and breastfeeding Autoimmune diseases (lupus, multiple sclerosis, etc.) Uncontrolled or insulin-treated diabetes Severe underlying neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment. Timepoint: at week 8-10 after termination of treatment. Method of measurement: based on PET scan and endoscopy report or surgical pathology report if performed. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Aqamolaei
Tehran University of Medical Sciences
Outcome results
None listed