Circulating Tumor DNA-based Minimal Residual Disease (MRD) Assessment in Local Advanced Esophageal Squamous Cell Carcinoma Treated by Definitive Concurrent Chemoradiotherapy

Fudan University1 site in 1 country100 target enrollmentJune 1, 2021

ConditionsEsophageal Squamous Cell Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Fudan University
Enrollment: 100
Locations: 1
Primary Endpoint: Relationship between ctDNA status after chemoradiotherapy and relapse.
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To analyze the relationship between the dynamic changes of circulating tumor DNA (ctDNA) and tumor relapse of esophageal squamous cell carcinoma treated by concurrent chemoradiotherapy.

Registry

clinicaltrials.gov

Start Date

June 1, 2021

End Date

December 1, 2024

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Kuai Le Zhao, MD

Professor

Fudan University

Eligibility Criteria

Inclusion Criteria

•18-75 years old.
•Esophageal squamous cell carcinoma confirmed by pathology.
•No radiotherapy, chemotherapy, or other treatments prior to enrollment.
•Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis).
•No severe abnormal hematopoietic, cardiac, pulmonary, renal, hepatic function, or immunodeficiency.
•Informed consent signed.

Exclusion Criteria

•Less than 50.4Gy/28fx of radiotherapy dose.
•Without Concurrent chemotherapy.
•Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.

Outcomes

Primary Outcomes

Relationship between ctDNA status after chemoradiotherapy and relapse.

Time Frame: ctDNA will be tested within 1 year after chemoradiotherapy

To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.

Secondary Outcomes

Relapse-free survival (RFS) and progression-free survival (PFS).(through study completion, an average of 2 years.)
Changes of ctDNA status.(before and at the end of radiotherapy (+1 week); at the end of consolidation chemotherapy (+1 week); at 2 weeks, 1 month, 3 months, 6 months, 9 months, 1 year after dCCRT.)
Overall survival (OS).(through study completion, an average of 2 years.)
Relationships between radiomics features, ctDNA status and relapse.(through study completion, an average of 2 years.)