Status:
RECRUITING
Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Rectal Cancer Stage I
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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/u...
Detailed Description
Baseline examnation: All enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (Incl. CEA, CA-199, ...
Eligibility Criteria
Inclusion
- Age ≥18 years, regardless of gender
- ECOG performance status 0-1
- Biopsy-proven rectal adenocarcinoma
- Distal margin of primary tumor ≤8 cm from anal verge
- Clinical stage I (cT1-2N0M0)
- Strong organ preservation preference with refusal to undergo abdominoperineal resection (Miles operation)
- The surgeon determined a local resection was feasible
- No contraindications to chemoradiotherapy
Exclusion
- Failure to meet the above inclusion criteria
- Patients refusing to sign informed consent
- Impaired cognitive function or psychiatric disorders
- Patients deemed ineligible by investigators
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2032
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06949098
Start Date
May 15 2025
End Date
May 1 2032
Last Update
May 29 2025
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China