Clinical trial · Interventional
Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low 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
NCT06949098CI-TRIAL-00120230recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer Stage I | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Local Tumor Resection | Procedure | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy
- description
- All enrolled patients will first undergo local tumor resection. Adjuvant therapy will be initiated 4-6 weeks postoperatively based on pathological staging: For pT1N0M0 patients without high-risk features: Active surveillance OR Radiotherapy alone (Prescription: Pelvic field irradiation 45Gy in 25 fractions) For pT2N0M0 or pT1N0M0 patients with adverse prognostic factors: Adjuvant chemoradiotherapy (Prescription:Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 5.4Gy in 3 fractions；Concurrent chemotherapy: Oral capecitabine 825mg/m² twice daily)；For patients with positive margins after local excision: Re-excision followed by adjuvant chemoradiotherapy OR Dose-escalated chemoradiotherapy (Prescription: Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 14.4Gy in 8 fractions)； For patients with staging \> pT2N0M0: Total mesorectal excision (TME) Following treatment completion, patients will enter clinical follow-up surveillance.
- interventionNames
- Procedure: Local Tumor Resection
- Radiation: Radiotherapy
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- 5-year DFS Rate
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.