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Recruiting Phase 3

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

NCT05984485 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2022-07-05
Last updated
2023-08-09

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

neoadjuvant chemotherapy plus total mesorectal excisiontotal mesorectal excision

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.

total mesorectal excision: Standard total mesorectal excision

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Newly diagnosed patients, aged 18 to 75 years; 2. Pathologically confirmed rectal adenocarcinoma; 3. Distance of the lower margin of the rectal tumor lesion from the anal margin \<15cm; 4. 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; 5. Exclusion of patients with non-local recurrence or distant metastases; 6. Absence of synchronous colorectal multiple primary cancers; 7. Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions; 8. The study physician assessed no difficulty in sphincter preservation; 9. patients and their families will be willing to participate in this study and provide written informed consent. Exclusion Criteria: 1. Patients with concurrent other malignancies or a history of malignant tumors in the past; 2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery; 3. Patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ resection; 4. Patients with poor anal function or fecal incontinence before surgery; 5. Patients with a history of inflammatory bowel disease or familial adenomatous polyposis; 6. Patients recently diagnosed with other malignancies; 7. Patients with ASA grade ≥ IV and/or ECOG performance status score \> 2; 8. Patients with severe liver or kidney dysfunction, significant cardiopulmonary impairment, coagulation disorders, or those with extreme underlying conditions unable to tolerate surgery; 9. Patients with a history of severe mental illness; 10. Pregnant or lactating women; 11. Patients with uncontrolled infections before surgery; 12. Patients with other clinical or laboratory conditions, as determined by the investigator, that render them unsuitable for participation in this trial.

Primary outcome measure(s)

  • 3-year Disease Free Survival — 3 years after surgery
    Defined as the proportion of patients who did not experience any of the following events from the beginning of the randomized subgroup to the end of the third year, which included disease progression, local recurrence, distant metastasis, or second primary colorectal cancer, or death from any cause.

Trial sites (6)

FacilityCityRegionStatus
Daping Hospital, Amy Medeical Univerisity Chongqing Chongqing Municipality Recruiting
Sun yat-sen University, the Sixth Affiliated Hospital Guangzhou Guangdong Recruiting
The First Affiliated Hospital of University of South China Hengyang Hunan Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi Recruiting
The Affiliated Nanchong Central Hospital of North Sichuan Medical College Nanchong Sichuan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05984485 on ClinicalTrials.gov ↗ ← All trials in China