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Recruiting
NCT06949098
Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer
Conditions: Rectal Cancer Stage I
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: Hebei Medical University Fourth Hospital
Location: The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years, regardless of gender
2. ECOG performance status 0-1
3. Biopsy-proven rectal adenocarcinoma
4. Distal margin of primary tumor ≤8 cm from anal verge
5. Clinical stage I (cT1-2N0M0)
6. Strong organ preservation preference with refusal to undergo abdominoperineal resection (Miles operation)
7. The surgeon determined a local resection was feasible
8. No contraindications to chemoradiotherapy
Exclusion Criteria:
1. Failure to meet the above inclusion criteria
2. Patients refusing to sign informed consent
3. Impaired cognitive function or psychiatric disorders
4. Patients deemed ineligible by investigators
Source: ClinicalTrials.gov (NCT06949098). StuddyBuddy aggregates publicly available trial information.