Menu
Recruiting NCT06949098

Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer

Phase II Interventional Rectal Cancer Stage I

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local Tumor Resection, Radiotherapy, Chemotherapy.
Who it may be relevant to
Registry conditions: Rectal Cancer Stage I. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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):

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.

Interventions

  • 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

Primary outcome measures

  • 5-year DFS Rate [Time frame: 5 years]
Secondary outcome measures (5)
  • 5-year Local Recurrence Rate [Time frame: 5 years]
  • 5-year Distant Metastasis Rate [Time frame: 5 years]
  • 5-year OS [Time frame: 5 years]
  • Sphincter Retention Rate [Time frame: 1 week after sugery]
  • Quality of Life (QoL) Scores [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Fourth Hospital of Hebei Medical University — Shijiazhuang

Identifiers

NCT: NCT06949098 · 2025043

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗