Status:

UNKNOWN

Development of a Genome-based Platform for Personalized Treatment in Locally Advanced Rectal Cancer Patients

Lead Sponsor:

Yonsei University

Conditions:

Locally Advanced Rectal Cancer

Eligibility:

All Genders

19+ years

Brief Summary

This study is aimed to develop a genome-based platform to predict patients who can achieve pathologic complete response after neoadjuvant treatment in locally advanced rectal cancer. The main treatmen...

Detailed Description

The treatment in this study is one of the standard treatments suggested by the NCCN guidelines. The patients received operation after neoadjuvant concurrent chemoradiotherapy and pathologic tumor resp...

Eligibility Criteria

Inclusion

  • Patients older than 19 years old
  • Clinically or histologically diagnosed rectal cancer (adenocarcinoma)
  • Patients who satisfy all of the following conditions with either rectal cancer stage T3-4 or T2 in lower rectal cancer with any N stage according to 8th edition of American Joint Committee on Cancer
  • \- Stage T3-4 (T2 in lower rectum) in CT or MRI
  • Performance status 0 or 1 based on ECOG
  • Patients agreed to provide the tissue sample
  • Diseases can be evaluated according to RECIST Version 1.1
  • Patients who voluntarily agreed to informed consent

Exclusion

  • Patients with distant metastasis
  • Patients with uncontrolled viral infection (HIV, HBV, HCV)
  • Patient who are pregnant, or have possibility of pregnancy and are on lactating
  • Hypersensitivity or history of allergic to the drug being used
  • Patients with cerebrovascular disease, complications, and infections that are not medically controlled
  • Patients with history of other malignant diseases within the past 5 years (excluding cured non-melanoma skin cancer or in situ cervical cancer)
  • Those who are taking drugs that can cause drug interactions with chemotherapy
  • Patients who withdraw consent

Key Trial Info

Start Date :

February 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 18 2025

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT04738214

Start Date

February 1 2021

End Date

January 18 2025

Last Update

February 4 2021

Active Locations (1)

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Yonsei University College of Medicine

Seoul, South Korea, 03722

Development of a Genome-based Platform for Personalized Treatment in Locally Advanced Rectal Cancer Patients | DecenTrialz