Back to resultsThe Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer (TaLaR-02)
Primary Purpose
Rectal Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
neoadjuvant chemotherapy plus total mesorectal excision
total mesorectal excision
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal cancer, total mesorectal excision, neoadjuvant chemotherapy
Eligibility Criteria
Inclusion Criteria: 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; Exclusion of patients with non-local recurrence or distant metastases; 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. Exclusion Criteria: 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.
Sites / Locations
- Daping Hospital, Amy Medeical UniverisityRecruiting
- Sun yat-sen University, the Sixth Affiliated HospitalRecruiting
- The First Affiliated Hospital of University of South ChinaRecruiting
- Shengjing Hospital of China Medical UniversityRecruiting
- The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- The Affiliated Nanchong Central Hospital of North Sichuan Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Primary total mesorectal excision
Neoadjuvant chemotherapy plus TME
Arm Description
Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.
Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Distance from the inferior resection margin to the tumor
The length between inferior resection margin and the tumor.
The status of circumferential margin
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
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
The days after surgery in the hospital
Time to Postoperative first feed
The duration after surgery to first feed
Time to Postoperative first gas
The duration after surgery to first gas
Postoperative pain
Postoperative pain according to pain socres
Postoperative anal function
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
Quality of life score would be based on EORTC QoL C30 scale.
3-year overall survival
5-year Disease Free Survival
5-year overall survival
Number of participants with treatment-related adverse events
It would be assessed by CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05984485
Brief Title
The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
Acronym
TaLaR-02
Official Title
TME vs TME+nCT in Low-risk LARC
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
July 2028 (Anticipated)
Study Completion Date
July 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal cancer, total mesorectal excision, neoadjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Primary TME
neoadjuvant chemotherapy plus TME
Masking
None (Open Label)
Allocation
Randomized
Enrollment
766 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Primary total mesorectal excision
Arm Type
Experimental
Arm Description
Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.
Arm Title
Neoadjuvant chemotherapy plus TME
Arm Type
Active Comparator
Arm Description
Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant chemotherapy plus total mesorectal excision
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
total mesorectal excision
Intervention Description
Standard total mesorectal excision
Primary Outcome Measure Information:
Title
3-year Disease Free Survival
Description
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.
Time Frame
3 years after surgery
Secondary Outcome Measure Information:
Title
Distance from the inferior resection margin to the tumor
Description
The length between inferior resection margin and the tumor.
Time Frame
Immediately after the surgery
Title
The status of circumferential margin
Description
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.
Time Frame
Immediately after the surgery
Title
The status of distal resection margin
Description
When the distance from the tumor to the distal resection margin was ≤ 10 mm, it was recorded as a positive distal resection margin.
Time Frame
Immediately after the surgery
Title
Postiveoperative stay
Description
The days after surgery in the hospital
Time Frame
1 months after surgery
Title
Time to Postoperative first feed
Description
The duration after surgery to first feed
Time Frame
1 months after surgery
Title
Time to Postoperative first gas
Description
The duration after surgery to first gas
Time Frame
1 months after surgery
Title
Postoperative pain
Description
Postoperative pain according to pain socres
Time Frame
1 months after surgery
Title
Postoperative anal function
Description
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.
Time Frame
3 years after the surgery
Title
Quality of life score
Description
Quality of life score would be based on EORTC QoL C30 scale.
Time Frame
3 years after the surgery
Title
3-year overall survival
Time Frame
3 years after the surgery
Title
5-year Disease Free Survival
Time Frame
5 years after the surgery
Title
5-year overall survival
Time Frame
5 years after the surgery
Title
Number of participants with treatment-related adverse events
Description
It would be assessed by CTCAE v4.0
Time Frame
1 month after neoadjuvant chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion of patients with non-local recurrence or distant metastases;
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huashan Liu, MD. PhD
Phone
+8613560309975
Email
liuhshan@mail2.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ziwei Zeng, MD,PhD
Phone
+8615521161750
Email
zengzw@mail2.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Kang, PhD,MD
Organizational Affiliation
Sun yat-sen University, sixth affiliated hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping Hospital, Amy Medeical Univerisity
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Tong, MD,PhD
Phone
+8613500321218
Email
vdtong@163.com
Facility Name
Sun yat-sen University, the Sixth Affiliated Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Kang, MD, PhD
Phone
+8613602886833
Email
kangl@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Huashan Liu, MD, PhD
Phone
+8613560309975
Email
liuhshan@mail2.sysu.edu.cn
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ouyang, MD,PhD
Phone
+8613973426200
Email
1847039906@qq.com
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhang, MD,PhD
Phone
+8618940257919
Email
haojiubujian1203@sina.cn
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongchun Song, MD,PhD
Phone
+8618991232549
Email
dr.songyongchun@qq.com
Facility Name
The Affiliated Nanchong Central Hospital of North Sichuan Medical College
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingyang Ren, MD,PhD
Phone
+8613890756658
Email
281746489@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Reasonable requests can provide relevant data, but must be used anonymously
Learn more about this trial
The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
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