NCT07297004

Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer

Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer: A Prospective, Single-arm, Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Research Objectives and Principles: Through a prospective study, explore the effectiveness and safety of stereotactic body radiation therapy (SBRT) in the treatment of unresectable locally recurrent rectal cancer (ULRRC), providing high-level evidence for the use of SBRT in ULRRC treatment. Primary Objective: R0 resection rate. Secondary Objectives: 1-year local progression-free survival (LPFS) and overall survival (OS), 2-year LPFS and OS, and side effects of the treatment. Study Design: A single-arm, open-label, prospective phase II study. Study Population and Expected Enrollment: Patients with unresectable locally recurrent rectal adenocarcinoma, with an expected enrollment of 20 patients. Scheduled Visits and Duration: December 2024 to November 2026. Trial Duration: December 2024 to November 2026. Intervention: SBRT for unresectable locally recurrent rectal cancer. Statistical Hypothesis: Enrolled patients are those with unresectable recurrent rectal cancer. Based on previous literature reports and retrospective clinical data from our center, it is hypothesized that the R0 resection rate for patients with unresectable locally recurrent colorectal cancer who do not receive SBRT is 20%, while the R0 resection rate for those receiving SBRT intervention is 50%. Using Simon's optimal two-stage study design, a single-arm study, with α set at 0.05 and 1-β at 0.80, and an expected loss to follow-up rate of 10%.

Conditions

• Unresectable Locally Recurrent Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	SBRT for unresectable locally recurrent rectal cancer

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: China