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Recruiting NCT05984485

The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer

Phase III Interventional Rectal Cancer

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: neoadjuvant chemotherapy plus total mesorectal excision, total mesorectal excision.
Who it may be relevant to
Registry conditions: Rectal Cancer. 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

TME vs TME+nCT in Low-risk LARC

Overview

Comparative analysis of the clinical efficacy between primary Total Mesorectal Excision (TME) surgery and neoadjuvant chemotherapy combined with TME surgery for low-risk locally advanced rectal cancer. Randomly enrolling eligible patients into either the control group receiving neoadjuvant chemotherapy combined with TME surgery or the experimental group receiving primary TME surgery, and subsequently comparing the clinical outcomes of the two groups

Interventions

  • Procedure neoadjuvant chemotherapy plus total mesorectal excision
    Neoadjuvant chemotherapy regimen recommended FOLFOX6, XELON, FOLFOX, mFOLFOX for 4-6 courses, and TME surgical treatment after preoperative tumor restaging 1-2 weeks after neoadjuvant chemotherapy.
  • Procedure total mesorectal excision
    Standard total mesorectal excision

Primary outcome measures

  • 3-year Disease Free Survival [Time frame: 3 years after surgery]
Secondary outcome measures (12)
  • Distance from the inferior resection margin to the tumor [Time frame: Immediately after the surgery]
  • The status of circumferential margin [Time frame: Immediately after the surgery]
  • The status of distal resection margin [Time frame: Immediately after the surgery]
  • Postiveoperative stay [Time frame: 1 months after surgery]
  • Time to Postoperative first feed [Time frame: 1 months after surgery]
  • Time to Postoperative first gas [Time frame: 1 months after surgery]
  • Postoperative pain [Time frame: 1 months after surgery]
  • Postoperative anal function [Time frame: 3 years after the surgery]
  • Quality of life score [Time frame: 3 years after the surgery]
  • 3-year overall survival [Time frame: 3 years after the surgery]
  • 5-year Disease Free Survival [Time frame: 5 years after the surgery]
  • 5-year overall survival [Time frame: 5 years after the surgery]

Eligibility criteria

Inclusion criteria

  • Newly diagnosed patients, aged 18 to 75 years;
  • Pathologically confirmed rectal adenocarcinoma;
  • Distance of the lower margin of the rectal tumor lesion from the anal margin <15cm;
  • High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the anal sphincter; negative mesorectal fascia (MRF) status; negative extramural vascular invasion (EMVI); no cancer nodules;
  • Exclusion of patients with non-local recurrence or distant metastases;
  • Absence of synchronous colorectal multiple primary cancers;
  • Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions;
  • The study physician assessed no difficulty in sphincter preservation;
  • patients and their families will be willing to participate in this study and provide written informed consent.

Exclusion criteria

  • Patients with concurrent other malignancies or a history of malignant tumors in the past;
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery;
  • Patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ resection;
  • Patients with poor anal function or fecal incontinence before surgery;
  • Patients with a history of inflammatory bowel disease or familial adenomatous polyposis;
  • Patients recently diagnosed with other malignancies;
  • Patients with ASA grade ≥ IV and/or ECOG performance status score > 2;
  • Patients with severe liver or kidney dysfunction, significant cardiopulmonary impairment, coagulation disorders, or those with extreme underlying conditions unable to tolerate surgery;
  • Patients with a history of severe mental illness;
  • Pregnant or lactating women;
  • Patients with uncontrolled infections before surgery;
  • Patients with other clinical or laboratory conditions, as determined by the investigator, that render them unsuitable for participation in this trial.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 6 centers
  • Daping Hospital, Amy Medeical Univerisity — Chongqing
  • Sun yat-sen University, the Sixth Affiliated Hospital — Guangzhou
  • The First Affiliated Hospital of University of South China — Hengyang
  • Shengjing Hospital of China Medical University — Shenyang
  • The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
  • The Affiliated Nanchong Central Hospital of North Sichuan Medical College — Nanchong

Identifiers

NCT: NCT05984485 · GIHSYSU-TaLaR-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗