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

Active, not recruiting

• Conditions: General Surgery; Radiology

• Registration Number: NCT06713824
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2024-10-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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-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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate	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	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 Outcome Measures

Name	Time	Method
Complication rate	30 days after surgery	Complications are common during post-operative treatment. Complication rate is the proportion of patients who experience an adverse event or secondary health problem as a result of the disease or the treatment provided. Some common complications include intestinal obstruction, wound infection, pneumonia, anastomotic fistula, chylous leak, and urinary tract infection (UTI).
Complications of radiation and chemotherapy	30 days after radiation and chemotherapy	Radiation and chemotherapy are essential cancer treatments but come with potential complications. Common radiation-related complications include skin reactions, fatigue, nausea, pulmonary toxicity, and bowel/bladder issues. Chemotherapy can lead to myelosuppression, nausea, alopecia, mucositis, and neuropathy. Measures to manage these complications include supportive care, prophylactic medications (e.g., antiemetics, growth factors), and close monitoring. Standards such as the CTCAE and Clavien-Dindo classification are used to assess and report the severity of adverse events. Personalized treatment plans, early intervention, and patient education are key to minimizing risks and improving patient outcomes.

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan