Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer
Recruiting · NCT06949098 · Interventional (participants receive a specific treatment) · Lead sponsor: Hebei Medical University Fourth Hospital
View the official record on ClinicalTrials.gov →Interventions studied
ChemotherapyLocal Tumor ResectionRadiotherapy
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- Failure to meet the above inclusion criteria
- Patients refusing to sign informed consent
- Impaired cognitive function or psychiatric disorders
- Patients deemed ineligible by investigators
Where it is running
1 location listed.
- The Fourth Hospital of Hebei Medical University - Shijiazhuang, Hebei, China