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NCT06061263 Clinical Trial

Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve PCR to Neoadjuvant Chemoradiotherapy

Esophageal Cancer Clinical Trial

Official title:
The Patterns and Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve Pathologic Complete Response to Neoadjuvant Chemoradiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06061263
Other study ID # 202212901
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date December 2023

Study information
Verified date September 2023
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It has been reported that patients with esophageal squamous cell carcinoma who achieved pathological complete response (PCR) to neoadjuvant chemoradiotherapy have better survival than those with non-PCR. Howeve, there is still recurrent diseases developed in PCR patients after esophagectomy. Herein, we aimed to investgate the risk factors of recurrence in PCR patients.

Description:

Between January 2008 and December 2018, a total of 96 patients with pathological complete response were enrolled in this study. Sterilized lymph nodes (SLN) were defined as those lymph nodes without residual tumor but with the presence of treatment response to neoadjuvant chemoradiotherapy. Prognostic factors for recurrence-free survival (RFS) were analyzed with univariate and multivariate analyses.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 96
Est. completion date December 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: (1) patients with histopathologically confirmed ESCC;(2) patients received nCRT and radical esophagectomy in our hospital;(3) patients received the cisplabin plus or cisplain plus as the preoperative chemotherapy regimen; (4) those patients achieved PCR in the postoperative specimens (both primary tumor and resected lymph nodes). Exclusion Criteria: (1) patients who did not receive preoperative treatment or received preoperative chemotherapy alone;(2) patients who underwent Ivor-Lewis esophagectomy or Sweet esophagectomy;(3) patients who received preoperative chemotherapy other than NP or DP regimens;(4) patients with non-PCR to nCRT.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• follow up
collecttion of clinicopathological data from a prespectively collected databse, including survival data.

Locations
Country Name City State
China Jianhua Fu Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence-free survival recurrence-free survival (RFS) was calculated from the date of esophagectomy to the date of first detected recurrent disease 2008-2018
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