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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer Stage I
• Intervention / Treatment: Procedure: Local Tumor Resection; Radiation: Radiotherapy; Drug: Chemotherapy

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):

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
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: chaoxi Zhou; Phone Number: 15931121563; Email: zhouchaoxi81@163.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Fourth Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: Local Tumor Resection; All enrolled patients will first undergo local tumor resection.; Radiation: Radiotherapy; 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.; Drug: Chemotherapy; Concurrent oral capecitabine 825 mg/m² twice daily with radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-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).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	5 years

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): May 1, 2032

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Local excision; Early rectal cancer; Adjuvant Chemoradiotherapy; Low/ultra-low rectal cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 2025043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No