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

RecruitingPhase 2Ages 18 Years - 75 YearsAllHebei Medical University Fourth Hospital
NCT06949098 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Local Tumor Resection
  • Radiotherapy
  • Chemotherapy
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Where

1 site
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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