The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer

NCT05984485 | Recruiting Phase 3 DMC

• 1 other identifier: GIHSYSU-TaLaR-02
• Study Type: interventional
• Target: 766
• Locations: 1 country
• Sites: 6

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

Conditions

Rectal Cancer

Keywords

Rectal cancer; total mesorectal excision; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 3-year Disease Free Survival

  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.

  3 years after surgery

Secondary Outcomes (13)

• Distance from the inferior resection margin to the tumor

  Immediately after the surgery

• The status of circumferential margin

  Immediately after the surgery

• The status of distal resection margin

  Immediately after the surgery

• Postiveoperative stay

  1 months after surgery

• Time to Postoperative first feed

  1 months after surgery

Study Arms (2)

Primary total mesorectal excision

EXPERIMENTAL

Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.

Procedure: total mesorectal excision

Neoadjuvant chemotherapy plus TME

ACTIVE COMPARATOR

Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.

Procedure: neoadjuvant chemotherapy plus total mesorectal excision

Interventions

neoadjuvant chemotherapy plus total mesorectal excision PROCEDURE

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.

Neoadjuvant chemotherapy plus TME

total mesorectal excision PROCEDURE

Standard total mesorectal excision

Primary total mesorectal excision

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (6)

Daping Hospital, Amy Medeical Univerisity

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Sun yat-sen University, the Sixth Affiliated Hospital

Guangzhou, Guangdong, 510655, China

RECRUITING

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

The Affiliated Nanchong Central Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Liang Kang, PhD,MD

  Sun yat-sen University, sixth affiliated hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huashan Liu, MD. PhD

CONTACT

+8613560309975; liuhshan@mail2.sysu.edu.cn

Ziwei Zeng, MD,PhD

CONTACT

+8615521161750; zengzw@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1. Primary TME 2. neoadjuvant chemotherapy plus TME

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 9, 2023
• Study Start: July 5, 2022
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

CN (6)