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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06061263
Collaborator
(none)
96
Enrollment
1
Location
19
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: follow up

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 Design

Study Type:
Observational
Actual Enrollment :
96 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Patterns and Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve Pathologic Complete Response to Neoadjuvant Chemoradiotherapy
Actual Study Start Date :
May 1, 2022
Actual Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
PCR patients with eaophageal squamous cell carcinomas

patients with esophageal squamous cell carcinoma (ESCC) patients who achieved pathologic complete response after neoadjuvant chemoradiotherapy (nCRT).

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

Outcome Measures

Primary Outcome Measures

  1. recurrence-free survival [2008-2018]

    recurrence-free survival (RFS) was calculated from the date of esophagectomy to the date of first detected recurrent disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jianhua Fu Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jianhua Fu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT06061263
Other Study ID Numbers:
  • 202212901
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jianhua Fu, Professor, Sun Yat-sen University
risk factor
Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma

Study Results

No Results Posted as of Sep 29, 2023