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

Phase 3

Recruiting

• Conditions: Rectal Cancer
• Interventions: Procedure: neoadjuvant chemotherapy plus total mesorectal excision; Procedure: total mesorectal excision

• Registration Number: NCT05984485
• Lead Sponsor: Sun Yat-sen University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-05
• Study First Submitted: 2023-07-21
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-08
• Last Update Submitted: 2023-08-08
• Study First Posted: 2023-08-09
• Last Update Posted: 2023-08-09
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 766

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy plus TME	neoadjuvant chemotherapy plus total mesorectal excision	Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.
Primary total mesorectal excision	total mesorectal excision	Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
The status of circumferential margin	Immediately after the surgery	When the distance from the tumor or malignant lymph node to the circumferential margin was ≤ 1 mm, it was recorded as a positive circumferential margin.
Time to Postoperative first feed	1 months after surgery	The duration after surgery to first feed
Postoperative pain	1 months after surgery	Postoperative pain according to pain socres
Number of participants with treatment-related adverse events	1 month after neoadjuvant chemotherapy	It would be assessed by CTCAE v4.0
The status of distal resection margin	Immediately after the surgery	When the distance from the tumor to the distal resection margin was ≤ 10 mm, it was recorded as a positive distal resection margin.
Postoperative anal function	3 years after the surgery	Anal function would be based on wexner Incontinence score. A total score of less than ten is considered good, and a score of more than ten is considered poor.
Quality of life score	3 years after the surgery	Quality of life score would be based on EORTC QoL C30 scale.
3-year overall survival	3 years after the surgery
Distance from the inferior resection margin to the tumor	Immediately after the surgery	The length between inferior resection margin and the tumor.
5-year overall survival	5 years after the surgery
Postiveoperative stay	1 months after surgery	The days after surgery in the hospital
Time to Postoperative first gas	1 months after surgery	The duration after surgery to first gas
5-year Disease Free Survival	5 years after the surgery

Trial Locations

Locations (6)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Daping Hospital, Amy Medeical Univerisity; 🇨🇳 Chongqing, Chongqing, China

The Affiliated Nanchong Central Hospital of North Sichuan Medical College; 🇨🇳 Nanchong, Sichuan, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Sun yat-sen University, the Sixth Affiliated Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of University of South China; 🇨🇳 Hengyang, Hunan, China