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

N/AActive Not RecruitingNCT06713824

Taichung Veterans General Hospital1,000 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

General Surgery Radiology

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 5-year postoperative period

Secondary Outcomes

Complication rate

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).

Time frame: 30 days after surgery

Complications of 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.

Data from ClinicalTrials.gov

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