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S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer

NCT02813967 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2020-09-16

No results posted yet for this study

Summary

This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.

Conditions

  • Esophageal Cancer
  • Chemoradiation

Interventions

RADIATION

Radiotherapy 54 Gy

Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.

RADIATION

Radiotherapy 60 Gy

Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.

DRUG

S-1

S-1 70mg/m2 was administered on days 1-14 and 29-42.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • MING CHEN, PHD · Zhejiang Cancer Hospital

  • XIANGHUI DU, MD · Zhejiang Cancer Hospital

  • youngling JI, MD · Zhejiang Cancer Hospital

  • weiguo zhu, MD · Huaian first people's hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02813967 on ClinicalTrials.gov