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

Launched by HEBEI MEDICAL UNIVERSITY FOURTH HOSPITAL · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment approach for patients with early-stage rectal cancer, specifically those with a tumor that is small and hasn’t spread (called T1-2N0M0). The study will involve 60 participants who will have their tumors removed through a procedure called local excision, followed by a combination of chemotherapy and radiation therapy to help prevent the cancer from returning. The goal is to find out how effective this method is in treating rectal cancer while preserving the organ.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of rectal adenocarcinoma, meaning they have cancer in the rectum. They should also be in good overall health and prefer to avoid a more invasive surgery that removes part of the rectum. Patients will be closely monitored throughout the study and receive support during their treatment. If you or a loved one is considering participation, it’s important to discuss any concerns with a healthcare provider to understand all the options available.

Gender

ALL

Eligibility criteria

• 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