Comparing surgery and chemotherapy for low-risk rectal cancer

TME vs TME+nCT in Low-risk LARC

This study is testing whether having surgery alone or surgery after chemotherapy works better for people with low-risk rectal cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 766 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Chongqing, Chongqing Municipality and 5 other locations)
• Trial ID: NCT05984485 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of primary Total Mesorectal Excision (TME) surgery against neoadjuvant chemotherapy combined with TME surgery in patients with low-risk locally advanced rectal cancer. Eligible participants will be randomly assigned to either receive chemotherapy followed by surgery or undergo surgery alone. The clinical outcomes of both groups will be analyzed to determine which approach yields better results for patients. This phase 3 trial aims to provide insights into optimal treatment strategies for this patient population.

Who should consider this trial

Good fit: Ideal candidates are newly diagnosed patients aged 18 to 75 with pathologically confirmed low-risk locally advanced rectal adenocarcinoma.

Not a fit: Patients with concurrent malignancies, distant metastases, or significant health issues that prevent them from tolerating surgery or chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the most effective treatment approach for low-risk locally advanced rectal cancer, potentially improving patient outcomes.

How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of TME surgery versus neoadjuvant chemotherapy is relatively novel.

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.

Where this trial is running

Chongqing, Chongqing Municipality and 5 other locations

• Daping Hospital, Amy Medeical Univerisity — Chongqing, Chongqing Municipality, China (Recruiting)
• Sun yat-sen University, the Sixth Affiliated Hospital — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (Recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
• The Affiliated Nanchong Central Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Liang Kang, PhD,MD — Sun yat-sen University, sixth affiliated hospital
• Study coordinator: Huashan Liu, MD. PhD

Conditions Rectal Cancer; Rectal cancer; total mesorectal excision; neoadjuvant chemotherapy