NCT06879197

Brief Summary

We evaluated all related clinical and pathologic data of patients with Locally Advanced Rectal Cancer following Neoadjuvant Chemoradiotherapy, including the pathologic regression grading, and other histopathologic characteristics. Finally, the present study was aimed at (1) clarifying the clinical significance of the Major Pathologic Regression for Locally Advanced Rectal Cancer following Locally Advanced Rectal Cancer and (2) comparing different Neoadjuvant Chemoradiotherapy treatments of this uncommon disease through conducting a large, multi-center cohort study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,187

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

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

April 30, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

6.7 years

First QC Date

March 11, 2025

Last Update Submit

March 11, 2025

Conditions

Rectal NeoplasmsChemotherapy Effect

Outcome Measures

Primary Outcomes (2)

  • PFS

    Progression free regression

    5 year

  • OS

    overall survival

    5 year

Eligibility Criteria

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

patients with Locally Advanced Rectal Cancer following Locally Advanced Rectal Cancer

You may qualify if:

  • Adults (≥18 years) diagnosed with locally advanced rectal adenocarcinoma (clinical stage II-III).
  • Completion of NCRT followed by curative-intent surgery. Availability of pre- and post-treatment histopathologic data, including standardized regression grading and digitized whole-slide images (WSIs).

You may not qualify if:

  • Metastatic disease at diagnosis. Incomplete clinical or pathologic records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

April 30, 2016

Primary Completion

December 30, 2022

Study Completion

March 30, 2023

Last Updated

March 17, 2025

Record last verified: 2025-03