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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06949098). StuddyBuddy aggregates publicly available trial information.