Rectal Cancer
Conditions
Keywords
Rectal cancer, total mesorectal excision, neoadjuvant chemotherapy
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
Interventions
PROCEDUREneoadjuvant 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.
PROCEDUREtotal mesorectal excision
Standard total mesorectal excision
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1. Primary TME 2. neoadjuvant chemotherapy plus TME
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Disease Free Survival | 3 years after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The status of circumferential margin | Immediately after the surgery | 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. |
| The status of distal resection margin | Immediately after the surgery | When the distance from the tumor to the distal resection margin was ≤ 10 mm, it was recorded as a positive distal resection margin. |
| Postiveoperative stay | 1 months after surgery | The days after surgery in the hospital |
| Time to Postoperative first feed | 1 months after surgery | The duration after surgery to first feed |
| Time to Postoperative first gas | 1 months after surgery | The duration after surgery to first gas |
| Postoperative pain | 1 months after surgery | Postoperative pain according to pain socres |
| Distance from the inferior resection margin to the tumor | Immediately after the surgery | The length between inferior resection margin and the tumor. |
| Quality of life score | 3 years after the surgery | Quality of life score would be based on EORTC QoL C30 scale. |
| 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 | 1 month after neoadjuvant chemotherapy | It would be assessed by CTCAE v4.0 |
| Postoperative anal function | 3 years after the surgery | 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. |
Countries
China
Contacts
Primary ContactHuashan Liu, MD. PhD
Backup ContactZiwei Zeng, MD,PhD
Outcome results
None listed