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Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
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: 1-year local progression-free survival (LPFS) . Secondary Objectives: R0 resection rate 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 40 patients. Scheduled Visits and Duration: December 2024 to November 2027. Trial Duration: December 2024 to November 2027. 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 1-year LPFS for patients with unresectable locally recurrent colorectal cancer who do not receive SBRT is 20%, while the 1-year LPFS for those receiving SBRT intervention is 40%. 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%.
Official title: Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer: A Prospective, Single-arm, Phase II Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-01-01
Completion Date
2026-11-30
Last Updated
2026-04-24
Healthy Volunteers
No
Interventions
Stereotactic Body Radiation Therapy (SBRT)
SBRT for unresectable locally recurrent rectal cancer
Locations (1)
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China