NCT05984485 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 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 766 participants |
| Start Date | 2022-07-05 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 766 participants in total. It began in 2022-07-05 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Liang Kang, PhD,MD
PRINCIPAL INVESTIGATOR
Sun yat-sen University, sixth affiliated hospital
Frequently Asked Questions
Who can join the NCT05984485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05984485 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 766 participants.
Is NCT05984485 currently recruiting?
Yes, NCT05984485 is actively recruiting participants. Contact the research team at liuhshan@mail2.sysu.edu.cn for enrollment information.
Where is the NCT05984485 trial being conducted?
This trial is being conducted at Chongqing, China, Guangzhou, China, Hengyang, China, Shenyang, China and 2 additional locations.
Who is sponsoring the NCT05984485 clinical trial?
NCT05984485 is sponsored by Sun Yat-sen University. The principal investigator is Liang Kang, PhD,MD at Sun yat-sen University, sixth affiliated hospital. The trial plans to enroll 766 participants.
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