Evaluation of preferred chemotherapy regimen during esophageal cancer radiotherapy

Phase 2

• Conditions: esophageal cancer.; Malignant neoplasm of esophagus

• Registration Number: IRCT20240701062297N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 98

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.