A Randomized Controlled Phase III Trial of Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer

National Cancer Center, Japan1 site in 1 country280 target enrollmentJuly 1, 2020

ConditionsEsophageal Squamous Cell Carcinoma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: National Cancer Center, Japan
Enrollment: 280
Locations: 1
Primary Endpoint: Major progression-free survival
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.

Registry

clinicaltrials.gov

Start Date

July 1, 2020

End Date

March 31, 2030

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Cancer Center, Japan

Responsible Party

Principal Investigator

Ken Kato

National Cancer Center Hospital

National Cancer Center, Japan

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Major progression-free survival

Time Frame: The primary analysis will be held 5-years after the last patient was enrolled.

If the remnant lesion in the esophagus or a recurrent lesion after complete response (CR) can be curatively removed by salvage EMR/ESD, it is not an event, and other progressions and deaths are events.

Secondary Outcomes

Overall survival(The primary analysis will be held 5-years after the last patient was enrolled.)
Esophagectomy-free survival(The primary analysis will be held 5-years after the last patient was enrolled.)
Long term toxicity(The primary analysis will be held 5-years after the last patient was enrolled.)
Complete response rate(The primary analysis will be held 5-years after the last patient was enrolled.)
Progression-free survival(The primary analysis will be held 5-years after the last patient was enrolled.)
Adverse events(The primary analysis will be held 5-years after the last patient was enrolled.)