Rectal Cancer
Conditions
Interventions
Pelvic radiotherapy group:Pelvic radiotherapy and adjuvant chemotherapy
Lateral region radiotherapy group:Lateral lymph node region radiotherapy and adjuvant chemotherapy
Non-radiotherapy group:Observation follow-up or adjuvant chemotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Mid- or low-rectal cancer (tumor center located at or below the peritoneal reflection). 2. Pathologically confirmed rectal adenocarcinoma. 3. Radiological diagnosis of cT2, cT3ab, or cT4a with negative circumferential resection margin (MRF). 4. Suspicious lateral lymph nodes meeting sentinel lymph node criteria (preoperative CT/MRI evaluation: node size 5–10 mm). 5. No prior treatment with radiotherapy or chemotherapy. 6. No evidence of distant metastases. 7. Comorbidities well-controlled: diabetes without complications and hypertension graded I–II. 8. ECOG performance status (PS) score of 0 to 1. 9. Age between 18 and 75 years.
Exclusion criteria
Exclusion criteria: 1. Patients with high rectal cancer (above the peritoneal reflection). 2. Presence of distant metastases or distant metastases after neoadjuvant chemotherapy. 3. Meeting the criteria for lateral lymph node burden (pre-treatment imaging shows lateral lymph node size =10 mm with changes in nodal margin or parenchymal signal density). 4. Patients requiring emergency surgery due to severe complications such as intestinal perforation, severe bowel obstruction, or gastrointestinal hemorrhage unmanageable with medical intervention. 5. History of rectal tumor surgery. 6. Inability to complete neoadjuvant chemoradiotherapy or curative surgery. 7. Patients with other malignant tumors. 8. Pregnant or lactating women. 9. Patients with major organ or systemic diseases, such as severe underlying diseases of vital organs (e.g., heart, lung, brain, kidney, liver) that render them unable to tolerate surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival rate (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year local recurrence rate;3-year overall survival (OS);carcinoembryonic antigen;Carbohydrate antigen199;The European Organisation for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30;European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29;International Prostate Symptom Score;Low Anterior Resection Syndrome Scoring System;Eastern Cooperative Oncology Group Performance Status;Pathological Results;Chest and abdominal CT, pelvic MRI, liver ultrasound/MRI, rectal ultrasound, colonoscopy, and biopsy results.; | — |
Countries
China
Contacts
Public ContactMeng Wenjian
Colorectal Cancer Center, Department of General Surgery, West China Hospital
Outcome results
None listed