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Clinical Trials/KCT0003367
KCT0003367
Completed
N/A

Effect of short-course radiotherapy followed by neoadjuvant Xelox (Capecitabine and Oxaliplatin) chemotherapy and total mesorectal excision in MRI defined high-risk rectal cancer: A phase II trial

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Yonsei University Health System, Severance Hospital
Enrollment
31
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
July 22, 2021
Last Updated
2 years ago
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. High\-risk patients of rectal cancer on pretreatment MRI using the following risk stratification system
  • ? Location of the lower part of the tumor is measured below less than 10 cm on the anal verge and lower part of the tumor is located below the lower limit of the peritoneal reflection.
  • ? If there is more than one, classify as a high risk group
  • ? Positive CRM threatening:
  • ? 5mm ? Extramural depth
  • ? Positive EMVI.
  • ? Positive Lateral pelvic LN metastasis
  • 2\. Between 19 and 80 years of age;
  • 3\. Satisfactory performance status: ECOG?2
  • 4\. American Society of Anesthesiologists (ASA) physical status classification system class I\~III

Exclusion Criteria

  • 1\. The evidenc of relapse of distant metastasis
  • 2\. Receiving treatment of other anti\-cancer drug or methods
  • 3\. Patients have low compliance and are not able to complete the entire trial
  • 4\. Presence of uncontrolled life\-threatening diseases
  • 5\. cT4 with infiltration of anterior organ on pretreatment MRI
  • 6\. cT4 with infiltration of internal or external anal sphincter on pretreatment MRI

Outcomes

Primary Outcomes

Not specified

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