RecruitingNot ApplicableNCT04519905

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

Sponsor

Fudan University

Enrollment

320 participants

Start Date

Jan 6, 2020

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma Chemoradiotherapy Survival

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.

Eligibility

Min Age: 76 Years

Inclusion Criteria10

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 Criteria10

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