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

Neoplasm, Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839002
• Other study ID #: CMISG1708
• Status: Completed
• Start date: May 21, 2010
• Est. completion date: March 15, 2023

Study information

• Verified date: April 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: March 15, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Neoplasm, Esophagus
• Neoplasms
• Neoplasms, Squamous Cell

Intervention

Procedure:
• nCRT
ESCC patients that recieved surgery and nCRT.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)