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

NCT06713824 | Active Not Recruiting DMC

• 1 other identifier: CE24540A
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

General Surgery; Radiology

Keywords

neo-adjuvant; rectal cancer; radiotherapy; concurrent chemo-radiation therapy

Outcome Measures

Primary Outcomes (2)

• Recurrence rate

  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.

  5-year postoperative period

• survival rate

  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.

  5-year postoperative period

Secondary Outcomes (2)

• Complication rate

  30 days after surgery

• Complications of radiation and chemotherapy

  30 days after radiation and chemotherapy

Study Arms (1)

neo-adjuvant radiotherapy and surgery

receive radiation therapy before surgery

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study collected clinical stage 3 rectal cancer patients who underwent radical resection without neoadjuvant radiotherapy at Taichung Veterans General Hospital from January 1, 2017 to October 1, 2024.

You may qualify if:

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

You may not qualify if:

• Non-rectal cancer.
• Clinical stage T1-T2.
• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 3, 2024
• Study Start: January 1, 2017
• Primary Completion: October 1, 2024
• Study Completion: November 30, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

TW (1)