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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06713824
Enrollment
1000
Registered
2024-12-03
Start date
2017-01-01
Completion date
2025-11-30
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Surgery, Radiology

Keywords

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

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.

Interventions

None listed

Sponsors

Taichung Veterans General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate5-year postoperative periodThe 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 rate5-year postoperative periodThis 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

MeasureTime frameDescription
Complication rate30 days after surgeryComplications 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 chemotherapy30 days after radiation and chemotherapyRadiation 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026