NCT06949098

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
73mo left

Started May 2025

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
May 2025May 2032

First Submitted

Initial submission to the registry

April 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2032

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2032

Last Updated

May 29, 2025

Status Verified

April 1, 2025

Enrollment Period

6.8 years

First QC Date

April 22, 2025

Last Update Submit

May 28, 2025

Conditions

Rectal Cancer Stage I

Keywords

Adjuvant ChemoradiotherapyLocal excisionLow/ultra-low rectal cancerEarly rectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 5-year Local Recurrence Rate

    5 years

  • 5-year Distant Metastasis Rate

    5 years

  • 5-year OS

    5 years

  • Sphincter Retention Rate

    1 week after sugery

  • Quality of Life (QoL) Scores

    5 years

Study Arms (1)

Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy

EXPERIMENTAL

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 ResectionRadiation: RadiotherapyDrug: Chemotherapy

Interventions

Local Tumor ResectionPROCEDURE

All enrolled patients will first undergo local tumor resection.

Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy
RadiotherapyRADIATION

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.

Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy
ChemotherapyDRUG

Concurrent oral capecitabine 825 mg/m² twice daily with radiotherapy

Local Tumor Excision +Postoperative Adjuvant Chemoradiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients refusing to sign informed consent
  • Impaired cognitive function or psychiatric disorders
  • Patients deemed ineligible by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

RadiotherapyDrug Therapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

chaoxi Zhou

CONTACT

15931121563zhouchaoxi81@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2025

First Posted

April 29, 2025

Study Start

May 15, 2025

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

May 1, 2032

Last Updated

May 29, 2025

Record last verified: 2025-04

Locations

CN(1)