NCT06617052

Preoperative (Chemo)Radiotherapy for Locally Recurrent Rectal Cancer

Efficacy and Safety of Preoperative (Chemo)Radiotherapy for Locally Recurrent Rectal Cancer: A Prospective, Single-arm Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Through an observational study, the efficacy and safety of preoperative chemoradiotherapy followed by surgery in patients with recurrent rectal cancer were assessed. The primary population included patients with (potentially) resectable locally recurrent rectal cancer, excluding those with distant metastases. The study design was a prospective, open-label, single-arm observational study. The primary endpoint was the pCR (pathological complete response) rate, while secondary endpoints included R0 resection rate, local recurrence-free survival, overall survival, and safety.

Conditions

• Locally Recurrent Rectal Cancer
• Preoperative Chemoradiotherapy

Timeline

• Start date: 2024-09-19
• Primary completion: 2028-08-31
• Completion: 2028-12-31
• First posted: 2024-09-27
• Last updated: 2024-09-27

Locations

1 site across 1 country: China