RecruitingPhase 2NCT06949098

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

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


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

60 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is for people with early-stage rectal cancer (stage I) who are located low in the rectum and want to avoid a major operation that would remove the rectum entirely. The study tests whether a less invasive local surgery (removing just the tumor) followed by radiation and chemotherapy can effectively treat the cancer while preserving the patient's bowel. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with stage I rectal cancer (limited to the rectal wall, no spread to lymph nodes or elsewhere) - Your tumor is located within 8 cm of the anal opening - You strongly prefer to avoid removal of the rectum (abdominoperineal resection) - Your surgeon has confirmed a local removal is technically possible **You may NOT be eligible if...** - You have significant cognitive issues or psychiatric conditions - You are unable to tolerate radiation and chemotherapy - You refuse to sign informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELocal Tumor Resection

All enrolled patients will first undergo local tumor resection.

RADIATIONRadiotherapy

Pelvic field irradiation 45Gy in 25 fractions plus Local tumor bed boost 5.4Gy in 3 fractions. For patients with positive surgical margins after local resection, a radiotherapy boost (pelvic field 45Gy/25 fractions + tumor bed local boost 14.4Gy/8 fractions) can be given.

DRUGChemotherapy

Concurrent oral capecitabine 825 mg/m² twice daily with radiotherapy


Locations(1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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NCT06949098