Rectal CancerPhase 3TaLaR-02NCT05984485
The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
A Phase 3 study testing neoadjuvant chemotherapy plus total mesorectal excision and total mesorectal excision in people with Rectal Cancer, run by Sun Yat-sen University at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- neoadjuvant chemotherapy plus total mesorectal excision and total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 766 participants
- Where
- 6 sitesChina
- Study dates
- 5 Jul 2022to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Daping Hospital, Amy Medeical Univerisity
Chongqing, Chongqing Municipality, 400042
Weidong Tong, MD,PhD, +8613500321218, vdtong@163.com
- Recruiting
Sun yat-sen University, the Sixth Affiliated Hospital
Guangzhou, Guangdong, 510655
Liang Kang, MD, PhD, +8613602886833, kangl@mail.sysu.edu.cn
Huashan Liu, MD, PhD, +8613560309975, liuhshan@mail2.sysu.edu.cn
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
Jun Ouyang, MD,PhD, +8613973426200, 1847039906@qq.com
- Recruiting
The Affiliated Nanchong Central Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Mingyang Ren, MD,PhD, +8613890756658, 281746489@qq.com
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Hong Zhang, MD,PhD, +8618940257919, haojiubujian1203@sina.cn
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yongchun Song, MD,PhD, +8618991232549, dr.songyongchun@qq.com
About this study
Official title: TME vs TME+nCT in Low-risk LARC
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
- Being tested
- neoadjuvant chemotherapy plus total mesorectal excision, total mesorectal excision
- Keywords
- Rectal cancer, total mesorectal excision, neoadjuvant chemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapy plus total mesorectal excisionProcedure or surgery
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.
total mesorectal excisionProcedure or surgery
Standard total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| Primary total mesorectal excision | Experimental | Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone. Receives: 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. Receives: Procedure: neoadjuvant chemotherapy plus total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years after surgery
Secondary outcomes (13)
Distance from the inferior resection margin to the tumor
The length between inferior resection margin and the tumor.
Measured: Immediately after the surgery
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.
Measured: Immediately after the surgery
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.
Measured: Immediately after the surgery
Postiveoperative stay
The days after surgery in the hospital
Measured: 1 months after surgery
Time to Postoperative first feed
The duration after surgery to first feed
Measured: 1 months after surgery
Time to Postoperative first gas
The duration after surgery to first gas
Measured: 1 months after surgery
Postoperative pain
Postoperative pain according to pain socres
Measured: 1 months after surgery
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.
Measured: 3 years after the surgery
Quality of life score
Quality of life score would be based on EORTC QoL C30 scale.
Measured: 3 years after the surgery
3-year overall survival
Measured: 3 years after the surgery
5-year Disease Free Survival
Measured: 5 years after the surgery
5-year overall survival
Measured: 5 years after the surgery
Number of participants with treatment-related adverse events
It would be assessed by CTCAE v4.0
Measured: 1 month after neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start5 Jul 2022
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Primary TME 2. neoadjuvant chemotherapy plus TME
- Masking
- None (open label)
- Enrolment
- 766 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Liang Kang, PhD,MD, Principal investigator, Sun yat-sen University, sixth affiliated hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984485
- Sponsor's protocol ID
- GIHSYSU-TaLaR-02
- Acronym
- TaLaR-02
- Status last verified
- Aug 2023
- First submitted
- 21 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Reasonable requests can provide relevant data, but must be used anonymously
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TME vs TME+nCT in Low-risk LARC
- ClinicalTrials.gov ID
- NCT05984485
- Acronym / sponsor ID
- TaLaR-02 / GIHSYSU-TaLaR-02
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, total mesorectal excision, neoadjuvant chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 766 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Primary TME 2. neoadjuvant chemotherapy plus TME
| Arm | Type | Receives |
|---|---|---|
| Primary total mesorectal excision | Experimental | Procedure: total mesorectal excisionPatients with low-risk locally advanced rectal cancer received total mesorectal excision alone. |
| Neoadjuvant chemotherapy plus TME | Active comparator | Procedure: neoadjuvant chemotherapy plus total mesorectal excisionPatients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant chemotherapy plus total mesorectal excisionNeoadjuvant 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 or surgery | Neoadjuvant chemotherapy plus TME |
| total mesorectal excisionStandard total mesorectal excision | Procedure or surgery | Primary total mesorectal excision |
Primary outcome
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.
13 secondary outcomes
Distance from the inferior resection margin to the tumor
Time frame: Immediately after the surgery
The status of circumferential margin
Time frame: Immediately after the surgery
The status of distal resection margin
Time frame: Immediately after the surgery
Postiveoperative stay
Time frame: 1 months after surgery
Time to Postoperative first feed
Time frame: 1 months after surgery
Time to Postoperative first gas
Time frame: 1 months after surgery
Postoperative pain
Time frame: 1 months after surgery
Postoperative anal function
Time frame: 3 years after the surgery
Quality of life score
Time frame: 3 years after the surgery
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: Undecided. Reasonable requests can provide relevant data, but must be used anonymously
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liang Kang, PhD,MD principal investigator
Sun yat-sen University, sixth affiliated hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing neoadjuvant chemotherapy plus total mesorectal excision and total mesorectal excision in people with Rectal Cancer, run by Sun Yat-sen University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huashan Liu, MD. PhD (+8613560309975, liuhshan@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Disease Free Survival (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.