Clinical trial NCT05984485: The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
Official title: TME vs TME+nCT in Low-risk LARC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rectal Cancer
Keywords: Rectal cancer
total mesorectal excision
neoadjuvant chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 766
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Primary TME
2. neoadjuvant chemotherapy plus TME
Primary purpose: TREATMENT

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


Eligibility criteria: 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 outcomes:
measure: 3-year Disease Free Survival
timeFrame: 3 years after surgery
Secondary outcomes:
measure: Distance from the inferior resection margin to the tumor
timeFrame: Immediately after the surgery
measure: The status of circumferential margin
timeFrame: Immediately after the surgery
measure: The status of distal resection margin
timeFrame: Immediately after the surgery
measure: Postiveoperative stay
timeFrame: 1 months after surgery
measure: Time to Postoperative first feed
timeFrame: 1 months after surgery
measure: Time to Postoperative first gas
timeFrame: 1 months after surgery
measure: Postoperative pain
timeFrame: 1 months after surgery
measure: Postoperative anal function
timeFrame: 3 years after the surgery
measure: Quality of life score
timeFrame: 3 years after the surgery
measure: 3-year overall survival
timeFrame: 3 years after the surgery
measure: 5-year Disease Free Survival
timeFrame: 5 years after the surgery
measure: 5-year overall survival
timeFrame: 5 years after the surgery
measure: Number of participants with treatment-related adverse events
timeFrame: 1 month after neoadjuvant chemotherapy
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital, Amy Medeical Univerisity
state: Chongqing
city: Guangzhou
country: China
facility: Sun yat-sen University, the Sixth Affiliated Hospital
state: Guangdong
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Nanchong
country: China
facility: The Affiliated Nanchong Central Hospital of North Sichuan Medical College
state: Sichuan
Study officials:
affiliation: Sun yat-sen University, sixth affiliated hospital
name: Liang Kang, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: