Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis

Rectal Cancer Clinical Trial

Official title:

Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02979795
• Other study ID #: CMUH105-REC2-072
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2016
• Last updated: November 30, 2016
• Start date: November 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2016
• Source: China Medical University Hospital
• Contact: Kan Sun Clifford Chao, MD
• Phone: 886422052121
• Email: D94032[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy, Disabilities

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chemoradiation
• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor regression rate	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	No
Secondary	Disease free survival		5 year	No
Secondary	Overall survival		5 year	No
Secondary	Local recurrence		5 year	No
Secondary	Distant metastasis		5 year	No