Local excision and chemoradiotherapy for early-stage rectal cancer
Official title: 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
Run by Hebei Medical University Fourth Hospital · NCT06949098 · Data updated 2026-11-12
This study is testing whether a combination of surgery and follow-up treatments can help people with early-stage rectal cancer while keeping their bowel function intact.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | March 2032 |
| Study ends | May 2032 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT06949098 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with biopsy-proven rectal adenocarcinoma at clinical stage I who prefer organ preservation.
✕Probably not a fit
Patients with advanced rectal cancer or those who are not suitable for chemoradiotherapy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of local tumor excision followed by postoperative chemoradiotherapy in patients with early-stage low/ultra-low rectal cancer. It aims to enroll 60 patients with T1-2N0M0 rectal cancer, who will undergo a series of examinations and treatments based on their pathological staging. Patients will receive either active surveillance, radiotherapy, or adjuvant chemoradiotherapy depending on their risk factors after surgery. The study is designed to assess the outcomes of these treatment approaches in preserving organ function while effectively managing cancer.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with early-stage rectal cancer, potentially improving their quality of life.
How similar studies have gone: Other studies have shown promising results with similar approaches in treating early-stage rectal cancer, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China Recruiting
Study contacts
- Study coordinator: chaoxi Zhou
- Email: zhouchaoxi81@163.com
- Phone: 15931121563
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.