S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

NCT02913066 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2017-06-16

No results posted yet for this study

Summary

Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly:

Experimental group: radiotherapy combined with S-1 chemotherapy.

Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.

Conditions

Interventions

OTHER

S-1 concurrent radiotherapy

Radiotherapy 60\~66 Gray/28\~33 times (50.4\~60 Gray /28\~33 planning target volume times, 60\~66 Gray/28\~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1\~ 14 days, 21 days for a cycle.

OTHER

S-1 plus Cisplatin concurrent radiotherapy

Radiotherapy 60\~66 Gray/28\~33 times (50.4\~60 Gray /28\~30 planning target volume times, Gross tumor volume of primary tumor60\~66 Gray/28\~33), synchronous chemotherapy S-1 70 mg/m2 1\~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1\~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1\~ 14 days, plus cisplatin 25mg/m2 1\~ 4 days, 21 days for a cycle.

Sponsors & Collaborators

  • Mianyang Central Hospital

    lead OTHER

Principal Investigators

  • Bo Du X, Doctor · Mianyang Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • China

Study Locations

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Entities

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 NCT02913066 on ClinicalTrials.gov