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

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

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Key information

Conditions

Neoplasm, Esophagus Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasm, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nCRT

Procedure

ESCC patients that recieved surgery and nCRT.

Primary outcomes

Five-year survival of patients

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

Shanghai Zhongshan Hospital

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2021
Study completion: 2023
First posted: May 3, 2023
Registry last updated: May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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