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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary total mesorectal excision | Experimental | Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone. |
|
| Neoadjuvant chemotherapy plus TME | Active Comparator | Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant chemotherapy plus total mesorectal excision | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Distance from the inferior resection margin to the tumor | The length between inferior resection margin and the tumor. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huashan Liu, MD. PhD | Contact | +8613560309975 | liuhshan@mail2.sysu.edu.cn | |
| Ziwei Zeng, MD,PhD | Contact | +8615521161750 | zengzw@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Liang Kang, PhD,MD | Sun yat-sen University, sixth affiliated hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital, Amy Medeical Univerisity | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
Reasonable requests can provide relevant data, but must be used anonymously
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| total mesorectal excision | Procedure | Standard total mesorectal excision |
|
| 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. | Immediately after the surgery |
| Postiveoperative stay | The days after surgery in the hospital | 1 months after surgery |
| Time to Postoperative first feed | The duration after surgery to first feed | 1 months after surgery |
| Time to Postoperative first gas | The duration after surgery to first gas | 1 months after surgery |
| Postoperative pain | Postoperative pain according to pain socres | 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. | 3 years after the surgery |
| Quality of life score | Quality of life score would be based on EORTC QoL C30 scale. | 3 years after the surgery |
| 3-year overall survival | 3 years after the surgery |
| 5-year Disease Free Survival | 5 years after the surgery |
| 5-year overall survival | 5 years after the surgery |
| Number of participants with treatment-related adverse events | It would be assessed by CTCAE v4.0 | 1 month after neoadjuvant chemotherapy |
| Sun yat-sen University, the Sixth Affiliated Hospital | Recruiting | Guangzhou | Guangdong | 510655 | China |
|
| The First Affiliated Hospital of University of South China | Recruiting | Hengyang | Hunan | 421001 | China |
|
| Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110004 | China |
|
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
|
| The Affiliated Nanchong Central Hospital of North Sichuan Medical College | Recruiting | Nanchong | Sichuan | 637000 | China |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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