Status:
RECRUITING
The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Newly diagnosed patients, aged 18 to 75 years;
- Pathologically confirmed rectal adenocarcinoma;
- Distance of the lower margin of the rectal tumor lesion from the anal margin \<15cm;
- 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;
- Exclusion of patients with non-local recurrence or distant metastases;
- Absence of synchronous colorectal multiple primary cancers;
- Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions;
- The study physician assessed no difficulty in sphincter preservation;
- patients and their families will be willing to participate in this study and provide written informed consent.
Exclusion
- Patients with concurrent other malignancies or a history of malignant tumors in the past;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery;
- Patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ resection;
- Patients with poor anal function or fecal incontinence before surgery;
- Patients with a history of inflammatory bowel disease or familial adenomatous polyposis;
- Patients recently diagnosed with other malignancies;
- Patients with ASA grade ≥ IV and/or ECOG performance status score \> 2;
- Patients with severe liver or kidney dysfunction, significant cardiopulmonary impairment, coagulation disorders, or those with extreme underlying conditions unable to tolerate surgery;
- Patients with a history of severe mental illness;
- Pregnant or lactating women;
- Patients with uncontrolled infections before surgery;
- Patients with other clinical or laboratory conditions, as determined by the investigator, that render them unsuitable for participation in this trial.
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
766 Patients enrolled
Trial Details
Trial ID
NCT05984485
Start Date
July 5 2022
End Date
July 1 2028
Last Update
August 9 2023
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Daping Hospital, Amy Medeical Univerisity
Chongqing, Chongqing Municipality, China, 400042
2
Sun yat-sen University, the Sixth Affiliated Hospital
Guangzhou, Guangdong, China, 510655
3
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421001
4
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004