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

Active, not recruiting

• Conditions: Esophageal Cancer
• Interventions: Other: follow up

• Registration Number: NCT06061263
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-06-30
• Status Verified: 2023-09
• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-09-24
• Last Update Submitted: 2023-09-24
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 96

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCR patients with eaophageal squamous cell carcinomas	follow up	patients with esophageal squamous cell carcinoma (ESCC) patients who achieved pathologic complete response after neoadjuvant chemoradiotherapy (nCRT).

Primary Outcome Measures

Name	Time	Method
recurrence-free survival	2008-2018	recurrence-free survival (RFS) was calculated from the date of esophagectomy to the date of first detected recurrent disease

Trial Locations

Locations (1)

Jianhua Fu; 🇨🇳 Guangzhou, Guangdong, China