NCT06241079

Brief Summary

The goal of this multicenter retrospective cohort study is to evaluate the impact of different pathological regression types on survival and recurrence patterns, with a particular focus on ypT0N+ patients in patients with esophageal squamous cell carcinoma. The main questions it aims to answer are the survival and recurrence patterns among the different pathological regression types in patients with esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
582

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2003

Completed
19.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

19.1 years

First QC Date

January 18, 2024

Last Update Submit

February 2, 2024

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    the time from the date of surgery to death or last follow-up (2023.01.31)

    From date of surgery until the date of death from any cause or last follow-up, assessed up to 10 years.

Study Arms (4)

ypT0N0

Other: non-intervention

ypT0N+

Other: non-intervention

ypT+N0

Other: non-intervention

ypT+N+

Other: non-intervention

Interventions

non-interventionOTHER

non-intervention

ypT+N+ypT+N0ypT0N+ypT0N0

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with esophageal squamous cell carcinoma (ESCC) who received NCRT or neoadjuvant radiotherapy (NRT) followed by esophagectomy from 2003 to 2022

You may qualify if:

  • histologically confirmed potentially resectable ESCC, clinical stage T1-4N0-1M0 (stage I-III) according to the American Joint Committee on Cancer 6th edition staging criteria.

You may not qualify if:

  • incomplete surgical resection, two-dimensional radiotherapy, and incomplete clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

February 5, 2024

Study Start

March 31, 2003

Primary Completion

April 28, 2022

Study Completion

February 1, 2023

Last Updated

February 5, 2024

Record last verified: 2024-01