NCT04443985

Brief Summary

Due to colorectal cancer is the fourth most common malignancy in the world. Some patients had present locally advance stage and need to preoperative concurrent chemoradiation (CCRT) before radical surgery. But predictor for pathologic complete response (pCR) after preoperative CCRT remain unclear. Objectives: To identify possible factor for predict of pCR of rectal cancer after preoperative CCRT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

June 11, 2020

Last Update Submit

May 15, 2022

Conditions

Rectum Cancer

Keywords

Preoperative chemoradiationRectum cancerPathological complete response

Outcome Measures

Primary Outcomes (2)

  • Stage

    Pathological of Tumor follow by The American Joint Committee on Cancer (AJCC) edition 8

    1 month

  • Lymph node

    Pathological of lymph node follow by The American Joint Committee on Cancer (AJCC) edition 8

    1 month

Eligibility Criteria

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

Patients who were diagnosed with rectal cancer and received chemoradiation

You may qualify if:

  • rectal cancer and received preoperative chemoradiation

You may not qualify if:

  • distant organ metastasis
  • previous colorectal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Chairat Supsamutchai, MD

    Ramathibodi Hospital, Mahidol University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 23, 2020

Study Start

June 1, 2020

Primary Completion

July 20, 2020

Study Completion

August 10, 2020

Last Updated

May 20, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)