NCT06883084

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 in the primary tumor site and lymph node, 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 in the primary tumor site and lymph node, and (2) comparing different Neoadjuvant Chemoradiotherapy treatments of this uncommon disease through conducting a large, multi-center cohort study.

Trial Health

53
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,080

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2014

Completed
11.1 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

11.9 years

First QC Date

March 12, 2025

Last Update Submit

March 12, 2025

Conditions

Rectal CancerLymph Node Metastasis

Outcome Measures

Primary Outcomes (2)

  • PFS

    Progression free survival

    10 years

  • OS

    Overall survival

    10 years

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:

  • \- distant Metastatic disease at diagnosis. Incomplete clinical or pathologic records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 19, 2025

Study Start

January 30, 2014

Primary Completion

December 30, 2025

Study Completion

February 25, 2026

Last Updated

March 19, 2025

Record last verified: 2025-03