Primary Tumor Burden Score:A Novel Staging Parameter for ESCC After nCRT

Completed

• Conditions: Neoplasm, Squamous Cell; Neoplasm, Esophagus
• Interventions: Procedure: nCRT

• Registration Number: NCT05839002
• Lead Sponsor: Fudan University

Brief Summary

In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS).

Detailed Description

In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS), which will combine the proportion of residual primary tumor cells and pre-treatment pathological T stage (prepT stage). The investigators will also try to improve ypTNM stage by results of PTBS.

Study Timeline

• Study Start: 2010-05-21
• Primary Completion: 2021-12-01
• Study Completion: 2023-03-15
• Study First Submitted: 2023-03-29
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• Neoadjuvant chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma

Exclusion Criteria

• Patients receiving neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training cohort	nCRT	Training cohort will be used to find the best calculation and cut-off values for PTBS in ESCC after nCRT.
Validation cohort	nCRT	The study's conclusion will be verified in Zhongshan Hospital Xiamen branch.

Primary Outcome Measures

Name	Time	Method
Five-year survival of patients	From surgery to the end of follow-up(at least 5 years later)	The survival of the patients was recorded by follow-up for five years after surgery.