Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

Launched by FUDAN UNIVERSITY · Aug 19, 2020

Keywords

ClinConnect Summary

This clinical trial, known as ESO-Shanghai 15, is looking at the best treatment options for elderly patients (over 75 years old) with a type of cancer called esophageal squamous cell carcinoma (ESCC). The study compares two treatment approaches: one group will receive radiotherapy alone, while another group will get a combination of chemotherapy and radiotherapy. The main goal is to find out which treatment helps patients live longer, while also looking at their quality of life and any side effects they might experience.

To join the study, patients need to be at least 76 years old and have a confirmed diagnosis of locally advanced ESCC, meaning the cancer has spread but is still in the esophagus and nearby areas. They should not have received any prior treatment for their cancer and must be in generally good health. Participants can expect to receive either of the treatments and will be monitored for their health and well-being over a three-year period. This trial is important because it aims to provide clearer guidelines for treating older patients with this specific cancer, helping doctors make better treatment decisions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Indicates no limit on eligibility based on the sex of participants
• • The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
• • Esophageal squamous cell carcinoma confirmed by pathology
• • No radiotherapy, chemotherapy or other treatments prior to enrollment
• • Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
• • Use of an effective contraceptive for adults to prevent pregnancy
• • No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
• • No immunodeficiency
• • ECOG 0-1.
• • Life expectancy of more than 3 months.
• Exclusion Criteria:
• • Total radiotherapy dose cannot reach 61.2Gy/34Fx
• • Esophageal perforation, or hematemesis
• • History of radiotherapy or chemotherapy for esophageal cancer
• • History of surgery within 28 days before Day 1
• • History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)
• • Participation in other interventional clinical trials within 30 days
• • Pregnant or breast-feeding women or fertile patients
• • Drug addiction,
• • alcoholism or AIDS
• • Uncontrolled seizures or psychiatric disorders