A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC

Phase 3

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: Chemoradiotherapy

• Registration Number: NCT04328948
• Lead Sponsor: National Cancer Center, Japan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-29
• Study First Posted: 2020-04-01
• Study Start: 2020-07-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2030-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiation therapy with elective nodal irradiation	Chemoradiotherapy	Chemoradiotherapy consists of 5-FU (1,000 mg / m2, day1-4, day29-32), CDDP (75 mg /m2, day1, 29) and radiotherapy (50.4 Gy/28Fr)
Chemoradiation therapy with involved field irradiation	Chemoradiotherapy	Chemoradiotherapy consists of 5-FU (700 mg /m2, day1-4, day29-32), CDDP (70 mg /m2, day1,29) and radiotherapy (60 Gy/30Fr)

Primary Outcome Measures

Name	Time	Method
Major progression-free survival	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 Outcome Measures

Name	Time	Method
Overall survival	The primary analysis will be held 5-years after the last patient was enrolled.	From date of randomization to date of death, approximately 5 years.
Esophagectomy-free survival	The primary analysis will be held 5-years after the last patient was enrolled.	From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years.
Long term toxicity	The primary analysis will be held 5-years after the last patient was enrolled.	Number of participants with treatment-related adverse events after termination of CRT as assessed by CTCAE v4.0
Complete response rate	The primary analysis will be held 5-years after the last patient was enrolled.	CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy.
Progression-free survival	The primary analysis will be held 5-years after the last patient was enrolled.	From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.
Adverse events	The primary analysis will be held 5-years after the last patient was enrolled.	Number of participants with treatment-related adverse events during CRT as assessed by CTCAE v4.0

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan