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
Last Updated: 2023-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
766 participants
INTERVENTIONAL
2022-07-05
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. neoadjuvant chemotherapy plus TME
TREATMENT
NONE
Study Groups
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Primary total mesorectal excision
Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.
total mesorectal excision
Standard total mesorectal excision
Neoadjuvant chemotherapy plus TME
Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.
neoadjuvant 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.
Interventions
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neoadjuvant 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.
total mesorectal excision
Standard total mesorectal excision
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yanhong Deng
Professor
Principal Investigators
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Liang Kang, PhD,MD
Role: PRINCIPAL_INVESTIGATOR
Sun yat-sen University, sixth affiliated hospital
Locations
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Daping Hospital, Amy Medeical Univerisity
Chongqing, Chongqing Municipality, China
Sun yat-sen University, the Sixth Affiliated Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The Affiliated Nanchong Central Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GIHSYSU-TaLaR-02
Identifier Type: -
Identifier Source: org_study_id
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