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NCT Number: NCT06949098

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

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.

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Key information

Conditions

Rectal Cancer Stage I Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local Tumor Resection

Procedure

All enrolled patients will first undergo local tumor resection.

Radiotherapy

Radiation

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.

Chemotherapy

Drug

Concurrent oral capecitabine 825 mg/m² twice daily with radiotherapy

Primary outcomes

  1. 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

  1. 5-year Local Recurrence Rate

    Time frame: 5 years

    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.

  2. 5-year Distant Metastasis Rate

    Time frame: 5 years

    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.

  3. 5-year OS

    Time frame: 5 years

    The proportion of patients who remain alive (regardless of disease status) at 5 years after initial diagnosis or treatment initiation.

  4. Sphincter Retention Rate

    Time frame: 1 week after sugery

    The proportion of patients who successfully avoid permanent colostomy after rectal cancer treatment, maintaining natural anal sphincter function for defecation.

  5. Quality of Life (QoL) Scores

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

chaoxi Zhou

CONTACT

[email protected]

15931121563

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Apr 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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