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

Primary Tumor Burden Score: A Novel Staging Parameter Superior to ypT-category for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy

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

Study Overview

• Status: Completed
• Conditions: Neoplasm, Esophagus; Neoplasm, Squamous Cell
• Intervention / Treatment: Procedure: nCRT

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 Type: Observational
• Enrollment (Actual): 187

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with ESCC undergoing nCRT at the Department of Thoracic Surgery, Zhongshan Hospital of Fudan University (training cohort), and the Department of Thoracic Surgery, Zhongshan Hospital Xiamen Branch (validation cohort), between January 2010 and February 2019 were reviewed. The inclusion criteria were (I) thoracic ESCC; (II) McKeown or Ivor-Lewis transthoracic approach; (III) locally advanced resectable tumor with cT3-4aNany staging treated with nCRT; (IV) no history of concomitant or prior malignancy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training cohort; Training cohort will be used to find the best calculation and cut-off values for PTBS in ESCC after nCRT.	Procedure: nCRT; ESCC patients that recieved surgery and nCRT.
Validation cohort; The study's conclusion will be verified in Zhongshan Hospital Xiamen branch.	Procedure: nCRT; ESCC patients that recieved surgery and nCRT.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2010
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms; Esophageal Neoplasms; Neoplasms, Squamous Cell
• Other Study ID Numbers: CMISG1708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No