Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis

November 30, 2016 updated by: Kun-San Clifford Chao, China Medical University Hospital
Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that localized radiation not only destroys local tumor but also inhibits the growth of tumor at the remote site, has been observed. This effect is believed to be associated with tumor immune response. In addition, other immune checkpoint molecules, such as Programmed cell death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after CCRT, more than 50% of patients were still either having persistent disease or developed distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this project, thus, aims at exploring the evolution of factors that may affect the abscopal effect and immune checkpoint functions in tissues and in blood before and after CCRT.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

For most patients, preoperative chemoradiotherapy results in clinically tumor regression, but the degree of response varies among patients. There are approximately 40-60% of LARC patients treated with CCRT achieve some degree of pathologic response. However, there is yet an effective method before the commencement of CCRT that can predict how patients will respond to CCRT and can subsequently render better survival. Identify patents who will benefit most from CCRT is crucial not only in lowering treatment-related morbidity and sustaining local control but also to improve survival rate in LARC.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Rectal cancer patients in China Medical University Hospital (Age: 20 yrs and older)

Description

Inclusion Criteria:

  • Rectal cancer patients in China Medical University Hospital (Age limit: 20 yrs and older)

Exclusion Criteria:

  • Pregnancy, Disabilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor regression rate
Time Frame: within 8 weeks after completion of chemoradiotherapy
complete tumor regression rate(TRG) with tumor regression graded at at surgical resection at 8 weeks after completion of chemoradiotherapy
within 8 weeks after completion of chemoradiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 year
5 year
Disease free survival
Time Frame: 5 year
5 year
Local recurrence
Time Frame: 5 year
5 year
Distant metastasis
Time Frame: 5 year
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Kan Sun Clifford Chao, MD, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH105-REC2-072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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