An Exploratory Study of Local Resection Combined With Chemoradiotherapy in Patients With Low/Ultra-low Early-stage Rectal Cancer With a Strong Desire to Preserve the Anus
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Contact Information
Primary
chaoxi Zhou
zhouchaoxi81@163.com
15931121563
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2032-05
Participants
Target number of participants: 60
Treatments
Experimental: Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy
All enrolled patients will first undergo local tumor resection. Adjuvant therapy will be initiated 4-6 weeks postoperatively based on pathological staging:~For pT1N0M0 patients without high-risk features:~Active surveillance OR Radiotherapy alone (Prescription: Pelvic field irradiation 45Gy in 25 fractions)~For pT2N0M0 or pT1N0M0 patients with adverse prognostic factors:~Adjuvant chemoradiotherapy (Prescription:Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 5.4Gy in 3 fractions；Concurrent chemotherapy: Oral capecitabine 825mg/m² twice daily)；For patients with positive margins after local excision: Re-excision followed by adjuvant chemoradiotherapy OR Dose-escalated chemoradiotherapy (Prescription: Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 14.4Gy in 8 fractions)；~For patients with staging \> pT2N0M0:~Total mesorectal excision (TME) Following treatment completion, patients will enter clinical follow-up surveillance.
Related Therapeutic Areas
Sponsors
Leads: Hebei Medical University Fourth Hospital