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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
766
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.
Standard total mesorectal excision
Daping Hospital, Amy Medeical Univerisity
Chongqing, Chongqing Municipality, China
RECRUITINGSun yat-sen University, the Sixth Affiliated Hospital
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of University of South China
Hengyang, Hunan, China
RECRUITINGShengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGThe First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGThe Affiliated Nanchong Central Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
RECRUITING3-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.
Time frame: 3 years after surgery
Distance from the inferior resection margin to the tumor
The length between inferior resection margin and the tumor.
Time frame: Immediately after the surgery
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.
Time frame: Immediately after the surgery
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.
Time frame: Immediately after the surgery
Postiveoperative stay
The days after surgery in the hospital
Time frame: 1 months after surgery
Time to Postoperative first feed
The duration after surgery to first feed
Time frame: 1 months after surgery
Time to Postoperative first gas
The duration after surgery to first gas
Time frame: 1 months after surgery
Postoperative pain
Postoperative pain according to pain socres
Time frame: 1 months after surgery
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.
Time frame: 3 years after the surgery
Quality of life score
Quality of life score would be based on EORTC QoL C30 scale.
Time frame: 3 years after the surgery
3-year overall survival
Time frame: 3 years after the surgery
5-year Disease Free Survival
Time frame: 5 years after the surgery
5-year overall survival
Time frame: 5 years after the surgery
Number of participants with treatment-related adverse events
It would be assessed by CTCAE v4.0
Time frame: 1 month after neoadjuvant chemotherapy
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