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Clinical Trials/NCT06713824
NCT06713824
Active, not recruiting
Not Applicable

Neoadjuvant Radiotherapy Before Surgery for Rectal Cancer, Surgical and Oncological Outcome Analysis, Retrospective Case Control Study in a Single Institute.

Taichung Veterans General Hospital1 site in 1 country1,000 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Surgery
Sponsor
Taichung Veterans General Hospital
Enrollment
1000
Locations
1
Primary Endpoint
Recurrence rate
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Pre-operative radiotherapy for clinical stage 3 rectal cancer outcome analysis, retrospective case-control study.

Detailed Description

For clinical T3 rectal cancer, neo-adjuvant radiotherapy was proved to reduce local recurrent rate in the clinical trials. In this study, we analysis surgical and oncological outcomes of neo-adjuvant radiotherapy for stage 3 rectal cancer in the real world in a single institute and do further subgroups analysis as references for treatment plans.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
November 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Rectal cancer, clinical stage T3 or higher, with no distant metastasis.
  • Age \> =20 years, ASA class I-III.
  • Underwent surgery.
  • Complete medical records.

Exclusion Criteria

  • Non-rectal cancer.
  • Clinical stage T1-T
  • Stage IV with distant metastasis.
  • Age \< 20 years, ASA class IV-V.
  • Incomplete medical records.
  • HIV-positive patients (Human Immunodeficiency Virus).
  • Patients who completed treatment after October 1, 2024.

Outcomes

Primary Outcomes

Recurrence rate

Time Frame: 5-year postoperative period

The disease recurrence rate refers to the likelihood of a disease reappearing after initial treatment, encompassing both local recurrence and distant metastasis. Local recurrence is defined by medical standards as the reappearance of a tumor at the original site or nearby lymph nodes, typically confirmed through imaging or pathological examination and commonly occurring within 1-3 years post-surgery. Distant metastasis, on the other hand, is identified when tumor cells spread to distant organs, such as the liver, lungs, or bones, and is confirmed through imaging modalities (e.g., CT, MRI, or PET scans) or biopsy. The incidence of distant metastasis is closely related to tumor staging, such as the TNM classification.

survival rate

Time Frame: 5-year postoperative period

This refers to the percentage of patients who are alive at a certain point in time after treatment, often 5 years, from diagnosis or start of treatment. The 5-year survival rate is commonly used in cancer research.

Secondary Outcomes

  • Complication rate(30 days after surgery)
  • Complications of radiation and chemotherapy(30 days after radiation and chemotherapy)

Study Sites (1)

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