Local excision and chemoradiotherapy for early-stage 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

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: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT06949098 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven rectal adenocarcinoma at clinical stage I who prefer organ preservation.

Not a fit: Patients with advanced rectal cancer or those who are not suitable for chemoradiotherapy will not benefit from this study.

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 performed: Other studies have shown promising results with similar approaches in treating early-stage rectal cancer, indicating potential for success.

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

Where this trial is running

Shijiazhuang, Hebei

• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)

Study contacts

• Study coordinator: chaoxi Zhou

Conditions: Rectal Cancer Stage I, Adjuvant Chemoradiotherapy, Local excision, Low/ultra-low rectal cancer, Early rectal cancer