Trial Title:
The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
NCT ID:
NCT05984485
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Rectal cancer
total mesorectal excision
neoadjuvant chemotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
1. Primary TME
2. neoadjuvant chemotherapy plus TME
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
neoadjuvant chemotherapy plus total mesorectal excision
Description:
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.
Arm group label:
Neoadjuvant chemotherapy plus TME
Intervention type:
Procedure
Intervention name:
total mesorectal excision
Description:
Standard total mesorectal excision
Arm group label:
Primary total mesorectal excision
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Daping Hospital, Amy Medeical Univerisity
Address:
City:
Chongqing
Zip:
400042
Country:
China
Status:
Recruiting
Contact:
Last name:
Weidong Tong, MD,PhD
Phone:
+8613500321218
Email:
vdtong@163.com
Facility:
Name:
Sun yat-sen University, the Sixth Affiliated Hospital
Address:
City:
Guangzhou
Zip:
510655
Country:
China
Status:
Recruiting
Contact:
Last name:
Liang Kang, MD, PhD
Phone:
+8613602886833
Email:
kangl@mail.sysu.edu.cn
Contact backup:
Last name:
Huashan Liu, MD, PhD
Phone:
+8613560309975
Email:
liuhshan@mail2.sysu.edu.cn
Facility:
Name:
The First Affiliated Hospital of University of South China
Address:
City:
Hengyang
Zip:
421001
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Ouyang, MD,PhD
Phone:
+8613973426200
Email:
1847039906@qq.com
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Recruiting
Contact:
Last name:
Hong Zhang, MD,PhD
Phone:
+8618940257919
Email:
haojiubujian1203@sina.cn
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongchun Song, MD,PhD
Phone:
+8618991232549
Email:
dr.songyongchun@qq.com
Facility:
Name:
The Affiliated Nanchong Central Hospital of North Sichuan Medical College
Address:
City:
Nanchong
Zip:
637000
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingyang Ren, MD,PhD
Phone:
+8613890756658
Email:
281746489@qq.com
Start date:
July 5, 2022
Completion date:
July 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05984485
