RecruitingPhase 2

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

China60 participantsStarted 2025-05-15

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

5-year DFS Rate

Timeframe: 5 years

Trial details

NCT IDNCT06949098

SponsorHebei Medical University Fourth Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-03

Contact for this trial

chaoxi Zhou

15931121563 zhouchaoxi81@163.com

View on ClinicalTrials.gov More Rectal Cancer Stage I trials