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Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer

RECRUITINGPhase 2Sponsored by Hebei Medical University Fourth Hospital
Actively Recruiting
PhasePhase 2
SponsorHebei Medical University Fourth Hospital
Started2025-05-15
Est. completion2032-03
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06949098

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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

Conditions2

CancerRectal Cancer Stage I

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