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

NCT06061263 | Unknown

• 1 other identifier: 202212901
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

risk factor

Outcome Measures

Primary Outcomes (1)

• recurrence-free survival

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

  2008-2018

Study Arms (1)

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

Interventions

follow up OTHER

collecttion of clinicopathological data from a prespectively collected databse, including survival data.

PCR patients with eaophageal squamous cell carcinomas

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all the ESCC patients with PCR to nCRT betwee 2008 and 2018 who received cisplabin plus or cisplain plus as the preoperative chemotherapy regimen.

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Jianhua Fu

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: September 29, 2023
• Study Start: May 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 1, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)