Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis

NCT ID: NCT02979795

Last Updated: 2016-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-12-31

Brief Summary

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.

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.

Conditions

Rectal Cancer; Chemoradiation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Preoperative chemoradiotherapy

Preoperative chemoradiotherapy. 2.5 Gray/fraction (Total in 45-54 Gray)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy, Disabilities

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kun-San Clifford Chao

Cancer center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kan Sun Clifford Chao, MD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Kan Sun Clifford Chao, MD

Role: CONTACT

D94032@mail.cmuh.org.tw

886422052121 ext. 2976

Facility Contacts

Huang Chih-Yang, Ph.D

Role: primary

T96752@mail.cmuh.org.tw

886422052121 ext. 3677

Other Identifiers

CMUH105-REC2-072

Identifier Type: -

Identifier Source: org_study_id