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Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer
Sponsor: Hebei Medical University Fourth Hospital
Summary
This study is a single-center, single-arm, prospective clinical trial designed to evaluate the efficacy of local excision followed by postoperative chemoradiotherapy in patients with early-stage low/ultra-low rectal cancer. The study plans to enroll 60 patients with T1-2N0M0 low/ultra-low rectal cancer.
Official title: An Exploratory Study of Local Resection Combined With Chemoradiotherapy in Patients With Low/Ultra-low Early-stage Rectal Cancer With a Strong Desire to Preserve the Anus
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-05-15
Completion Date
2032-05
Last Updated
2025-05-29
Healthy Volunteers
No
Conditions
Interventions
Local Tumor Resection
All enrolled patients will first undergo local tumor resection.
Radiotherapy
Pelvic field irradiation 45Gy in 25 fractions plus Local tumor bed boost 5.4Gy in 3 fractions. For patients with positive surgical margins after local resection, a radiotherapy boost (pelvic field 45Gy/25 fractions + tumor bed local boost 14.4Gy/8 fractions) can be given.
Chemotherapy
Concurrent oral capecitabine 825 mg/m² twice daily with radiotherapy
Locations (1)
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China