ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426850
• Other study ID #: ESO-Shanghai16
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old.

2. ECOG 0-1.

3. Esophageal squamous cell carcinoma confirmed by pathology.

4. No radiotherapy, chemotherapy, or other treatments prior to enrollment.

5. Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis).

6. No severe abnormal hematopoietic, cardiac, pulmonary, renal, hepatic function, or immunodeficiency.

7. Informed consent signed.

Exclusion Criteria:

1. Less than 50.4Gy/28fx of radiotherapy dose.

2. Without Concurrent chemotherapy.

3. Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Locations

Country	Name	City	State
China	Fudan University Shanghai cancer center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between ctDNA status after chemoradiotherapy and relapse.	To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.	ctDNA will be tested within 1 year after chemoradiotherapy
Secondary	Changes of ctDNA status.	To dynamically evaluate the ctDNA status at baseline, during treatment and follow-up.	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.
Secondary	Overall survival (OS).	To compare OS in ctDNA(+) patients and ctDNA(-) patients.	through study completion, an average of 2 years.
Secondary	Relapse-free survival (RFS) and progression-free survival (PFS).	To compare RFS and PFS in ctDNA(+) patients and ctDNA(-) patients.	through study completion, an average of 2 years.
Secondary	Relationships between radiomics features, ctDNA status and relapse.	To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma compared to traditional radiographic methods.	through study completion, an average of 2 years.