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The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer (TaLaR-02)

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ClinicalTrials.gov Identifier: NCT05984485
Recruitment Status : Recruiting
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University

Study Description
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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

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: neoadjuvant chemotherapy plus total mesorectal excision Procedure: total mesorectal excision Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 766 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Primary TME
  2. neoadjuvant chemotherapy plus TME
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TME vs TME+nCT in Low-risk LARC
Actual Study Start Date : July 5, 2022
Estimated Primary Completion Date : July 2028
Estimated Study Completion Date : July 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: Primary total mesorectal excision
Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.
 Procedure: total mesorectal excision
Standard total mesorectal excision
Active Comparator: Neoadjuvant chemotherapy plus TME
Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 3-year Disease Free Survival [ Time Frame: 3 years after surgery ]
    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.


Secondary Outcome Measures :
  1. Distance from the inferior resection margin to the tumor [ Time Frame: Immediately after the surgery ]
    The length between inferior resection margin and the tumor.

  2. The status of circumferential margin [ Time Frame: Immediately after the surgery ]
    When the distance from the tumor or malignant lymph node to the circumferential margin was ≤ 1 mm, it was recorded as a positive circumferential margin.

  3. The status of distal resection margin [ Time Frame: Immediately after the surgery ]
    When the distance from the tumor to the distal resection margin was ≤ 10 mm, it was recorded as a positive distal resection margin.

  4. Postiveoperative stay [ Time Frame: 1 months after surgery ]
    The days after surgery in the hospital

  5. Time to Postoperative first feed [ Time Frame: 1 months after surgery ]
    The duration after surgery to first feed

  6. Time to Postoperative first gas [ Time Frame: 1 months after surgery ]
    The duration after surgery to first gas

  7. Postoperative pain [ Time Frame: 1 months after surgery ]
    Postoperative pain according to pain socres

  8. Postoperative anal function [ Time Frame: 3 years after the surgery ]
    Anal function would be based on wexner Incontinence score. A total score of less than ten is considered good, and a score of more than ten is considered poor.

  9. Quality of life score [ Time Frame: 3 years after the surgery ]
    Quality of life score would be based on EORTC QoL C30 scale.

  10. 3-year overall survival [ Time Frame: 3 years after the surgery ]
  11. 5-year Disease Free Survival [ Time Frame: 5 years after the surgery ]
  12. 5-year overall survival [ Time Frame: 5 years after the surgery ]
  13. Number of participants with treatment-related adverse events [ Time Frame: 1 month after neoadjuvant chemotherapy ]
    It would be assessed by CTCAE v4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984485


Contacts
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Contact: Huashan Liu, MD. PhD +8613560309975 liuhshan@mail2.sysu.edu.cn
Contact: Ziwei Zeng, MD,PhD +8615521161750 zengzw@mail2.sysu.edu.cn

Locations
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China, Chongqing
Daping Hospital, Amy Medeical Univerisity Recruiting
Chongqing, Chongqing, China, 400042
Contact: Weidong Tong, MD,PhD    +8613500321218    vdtong@163.com   
China, Guangdong
Sun yat-sen University, the Sixth Affiliated Hospital Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Liang Kang, MD, PhD    +8613602886833    kangl@mail.sysu.edu.cn   
Contact: Huashan Liu, MD, PhD    +8613560309975    liuhshan@mail2.sysu.edu.cn   
China, Hunan
The First Affiliated Hospital of University of South China Recruiting
Hengyang, Hunan, China, 421001
Contact: Jun Ouyang, MD,PhD    +8613973426200    1847039906@qq.com   
China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Hong Zhang, MD,PhD    +8618940257919    haojiubujian1203@sina.cn   
China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Yongchun Song, MD,PhD    +8618991232549    dr.songyongchun@qq.com   
China, Sichuan
The Affiliated Nanchong Central Hospital of North Sichuan Medical College Recruiting
Nanchong, Sichuan, China, 637000
Contact: Mingyang Ren, MD,PhD    +8613890756658    281746489@qq.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Liang Kang, PhD,MD Sun yat-sen University, sixth affiliated hospital
More Information
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Responsible Party: Yanhong Deng, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT05984485    
Other Study ID Numbers: GIHSYSU-TaLaR-02
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Reasonable requests can provide relevant data, but must be used anonymously

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanhong Deng, Sun Yat-sen University:
Rectal cancer
total mesorectal excision
neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases