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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

Tracking Information
First Submitted Date  ICMJE July 21, 2023
First Posted Date  ICMJE August 9, 2023
Last Update Posted Date August 9, 2023
Actual Study Start Date  ICMJE July 5, 2022
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2023)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2023)
  • Distance from the inferior resection margin to the tumor [ Time Frame: Immediately after the surgery ]
    The length between inferior resection margin and the tumor.
  • 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.
  • 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.
  • Postiveoperative stay [ Time Frame: 1 months after surgery ]
    The days after surgery in the hospital
  • Time to Postoperative first feed [ Time Frame: 1 months after surgery ]
    The duration after surgery to first feed
  • Time to Postoperative first gas [ Time Frame: 1 months after surgery ]
    The duration after surgery to first gas
  • Postoperative pain [ Time Frame: 1 months after surgery ]
    Postoperative pain according to pain socres
  • 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.
  • Quality of life score [ Time Frame: 3 years after the surgery ]
    Quality of life score would be based on EORTC QoL C30 scale.
  • 3-year overall survival [ Time Frame: 3 years after the surgery ]
  • 5-year Disease Free Survival [ Time Frame: 5 years after the surgery ]
  • 5-year overall survival [ Time Frame: 5 years after the surgery ]
  • Number of participants with treatment-related adverse events [ Time Frame: 1 month after neoadjuvant chemotherapy ]
    It would be assessed by CTCAE v4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
Official Title  ICMJE TME vs TME+nCT in Low-risk LARC
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Primary TME
  2. neoadjuvant chemotherapy plus TME
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • 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.
  • Procedure: total mesorectal excision
    Standard total mesorectal excision
Study Arms  ICMJE
  • Experimental: Primary total mesorectal excision
    Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.
    Intervention: Procedure: total mesorectal excision
  • Active Comparator: Neoadjuvant chemotherapy plus TME
    Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.
    Intervention: Procedure: neoadjuvant chemotherapy plus total mesorectal excision
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2023)		 766
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2028
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Huashan Liu, MD. PhD +8613560309975 liuhshan@mail2.sysu.edu.cn
Contact: Ziwei Zeng, MD,PhD +8615521161750 zengzw@mail2.sysu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05984485
Other Study ID Numbers  ICMJE GIHSYSU-TaLaR-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Reasonable requests can provide relevant data, but must be used anonymously
Current Responsible Party Yanhong Deng, Sun Yat-sen University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sun Yat-sen University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Liang Kang, PhD,MD Sun yat-sen University, sixth affiliated hospital
PRS Account Sun Yat-sen University
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP