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

Rectal Cancer Clinical Trial

— TaLaR-02  

Official title:

TME vs TME+nCT in Low-risk LARC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984485
• Other study ID #: GIHSYSU-TaLaR-02
• Status: Recruiting
• Phase: Phase 3
• Start date: July 5, 2022
• Est. completion date: July 2028

Study information

• Verified date: August 2023
• Source: Sun Yat-sen University
• Contact: Huashan Liu, MD. PhD
• Phone: +8613560309975
• Email: liuhshan[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 766
• Est. completion date: July 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.
• total mesorectal excision
Standard total mesorectal excision

Locations

Country	Name	City	State
China	Daping Hospital, Amy Medeical Univerisity	Chongqing	Chongqing
China	Sun yat-sen University, the Sixth Affiliated Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan
China	The Affiliated Nanchong Central Hospital of North Sichuan Medical College	Nanchong	Sichuan
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year Disease Free Survival	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.	3 years after surgery
Secondary	Distance from the inferior resection margin to the tumor	The length between inferior resection margin and the tumor.	Immediately after the surgery
Secondary	The status of circumferential margin	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.	Immediately after the surgery
Secondary	The status of distal resection margin	When the distance from the tumor to the distal resection margin was = 10 mm, it was recorded as a positive distal resection margin.	Immediately after the surgery
Secondary	Postiveoperative stay	The days after surgery in the hospital	1 months after surgery
Secondary	Time to Postoperative first feed	The duration after surgery to first feed	1 months after surgery
Secondary	Time to Postoperative first gas	The duration after surgery to first gas	1 months after surgery
Secondary	Postoperative pain	Postoperative pain according to pain socres	1 months after surgery
Secondary	Postoperative anal function	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.	3 years after the surgery
Secondary	Quality of life score	Quality of life score would be based on EORTC QoL C30 scale.	3 years after the surgery
Secondary	3-year overall survival		3 years after the surgery
Secondary	5-year Disease Free Survival		5 years after the surgery
Secondary	5-year overall survival		5 years after the surgery
Secondary	Number of participants with treatment-related adverse events	It would be assessed by CTCAE v4.0	1 month after neoadjuvant chemotherapy