CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 298 enrolled
Drug / intervention
S-1 +2 moredrug
Likely dose
S-1 70mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02813967
NCT02813967Phase 3Completed
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S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Prospective, Randomized, Multi-center Phase-III Study

Zhejiang Cancer Hospital·interventional·Posted Jun 27, 2016·Updated Sep 16, 2020

In Brief

A Phase 3 clinical trial evaluating Radiotherapy 54 Gy, Radiotherapy 60 Gy, and 1 other intervention for Esophageal Cancer and Chemoradiation. Completed, enrolled 298 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer, Chemoradiation
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 27, 2016
Enrollment StartJun 1, 2016
Primary CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 10.0 years ago

Interventions

Radiotherapy 54 Gyradiation

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

Radiotherapy 60 Gyradiation

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

S-1drug

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