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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 5-year DFS Rate
Study Overview
Brief 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.
Detailed Description
Baseline examnation: All enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (Incl. CEA, CA-199, CA-724 β2-microglobulin, Ferroprotein), chest CT, abdominal and pelvic MRI, etc., were required to undergo KRAS, NRAS, BREF, PD-L1, MMR/MSS testings before surgery, and blood lymphocyte subgroups were analyzed before surgery.
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 (including poorly differentiated histology, lymphovascular invasion, positive margins*, tumor infiltration beyond the outer third of the submucosal muscle layer（SM3 level）, or submucosal invasion >1mm):
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy
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.
Intervention: Chemotherapy (Drug)
Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy
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.
Intervention: Local Tumor Resection (Procedure)
Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy
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.
Intervention: Radiotherapy (Radiation)
Outcomes
Primary Outcomes
5-year DFS Rate
Time Frame: 5 years
Defined as the proportion of subjects who remain free from recurrence, progression, or death for 5 years after completing surgery and adjuvant chemoradiotherapy (estimated as the proportion of event-free patients based on survival curves).
Secondary Outcomes
- Sphincter Retention Rate(1 week after sugery)
- Quality of Life (QoL) Scores(5 years)
- 5-year Local Recurrence Rate(5 years)
- 5-year Distant Metastasis Rate(5 years)
- 5-year OS(5 years)