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

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

So far, there is no specific clinical guideline for elderly patients (>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Fujian Cancer Hospital; Gansu Cancer Hospital; Huadong Hospital; Jiangsu Cancer Institute & Hospital; Ningbo No.2 Hospital; Taihe Hospital; The First Affiliated Hospital of Xiamen University; Wuxi No. 4 People's Hospital
• Treatments: Carboplatin; Paclitaxel

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