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.
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): 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
All enrolled patients will first undergo local tumor resection.
Pelvic field irradiation 45Gy in 25 fractions plus Local tumor bed boost 5.4Gy in 3 fractions. For patients with positive surgical margins after local resection, a radiotherapy boost (pelvic field 45Gy/25 fractions + tumor bed local boost 14.4Gy/8 fractions) can be given.
Concurrent oral capecitabine 825 mg/m² twice daily with radiotherapy
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITING5-year DFS Rate
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).
Time frame: 5 years
5-year Local Recurrence Rate
The proportion of patients who experience tumor recurrence at or near the primary tumor site (within the pelvic region) within 5 years after initial treatment completion.
Time frame: 5 years
5-year Distant Metastasis Rate
The proportion of patients who develop metastatic disease in distant organs (e.g., liver, lungs, bones, or non-regional lymph nodes) within 5 years after initial treatment.
Time frame: 5 years
5-year OS
The proportion of patients who remain alive (regardless of disease status) at 5 years after initial diagnosis or treatment initiation.
Time frame: 5 years
Sphincter Retention Rate
The proportion of patients who successfully avoid permanent colostomy after rectal cancer treatment, maintaining natural anal sphincter function for defecation.
Time frame: 1 week after sugery
Quality of Life (QoL) Scores
Calculated based on standardized scores, with proportions of patients showing marked improvement, improvement, no change, or worsening. Specific calculation rules are provided in the appendix.
Time frame: 5 years
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