A Randomized Clinical trial comparing FOLFOX to CP chemotherapy regimens with addition of immunotherapy in the neoadjuvant chemoradiotherapy treatment of esophageal cancer based on complete pathological/clinical response in PET scan or surgery

Tehran University of Medical Sciences0 个研究点目标入组 98 人开始时间: 待定最近更新: 2024年7月22日

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•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

•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

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