Colon CancerPhase 3BLARCCNCT06709144
Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer
A Phase 3 study testing SMA lymph node dissection and SMV lymph node dissection in people with Colon Cancer, run by Haixing Ju, MD at 1 site in China.
Trial summary
The study was conducted on patients with advanced right-sided colon cancer, and the clinical pathological and prognostic data of the patients were compared between the two groups of patients who were randomly divided into those undergoing SMV and SMA left resection, with the aim of resolving the controversy over the… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- SMA lymph node dissection and SMV lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 896 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jun 2032
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- right side colon cancer(The primary lesion is located in the ileocecal region, ascending colon, hepatic flexure of colon, or proximal transverse colon)
- T3-4 and/or N1-2M0
- Colonoscopy and pathological biopsy confirmed colon adenocarcinoma
Who cannot join
- T1-2N0M0
- Cannot undergo curative resection
- Simultaneous multiple primary colorectal cancer or other diseases requiring segmental resection
- Distant metastasis
- Tumor invades surrounding organs, requiring joint organ resection
- Emergency surgery is required for complications such as intestinal obstruction, perforation, and bleeding
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- Patients who have received neoadjuvant therapy before surgery
- Pregnant or lactating women
- Patients who are not suitable or unable to tolerate surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer(BLARCC): a Prospective, Multicenter Randomized Control Clinical Trial
The study was conducted on patients with advanced right-sided colon cancer, and the clinical pathological and prognostic data of the patients were compared between the two groups of patients who were randomly divided into those undergoing SMV and SMA left resection, with the aim of resolving the controversy over the left resection boundary of CME/D3 lymph node dissection through this study, and to clarify whether SMA left resection is superior to SMV left resection.
- Conditions
- Colon Cancer
- Being tested
- SMA lymph node dissection, SMV lymph node dissection
- Keywords
- right side colon cancer, complete mesentery resection
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMA lymph node dissectionProcedure or surgery
The lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA)
SMV lymph node dissectionProcedure or surgery
The lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV)
| Study group | Role | What they receive |
|---|---|---|
| Group SMA | Experimental | The lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA). Receives: Procedure: SMA lymph node dissection |
| Group SMV | Active comparator | The lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV) Receives: Procedure: SMV lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year DFS
3 year disease free survival
Measured: 3 years
Secondary outcomes (1)
5 year OS
5 year Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 896 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haixing Ju, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangxi Provincial Cancer Hospital, Jiangsu Cancer Institute & Hospital, Liaoning Cancer Hospital & Institute, The First Affiliated Hospital of Soochow University, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Shanxi Medical University, Shaoxing People's Hospital, Shaoxing Second Hospital, Ningbo No. 1 Hospital, Ningbo No.2 Hospital, Jinhua Central Hospital, Affiliated Hospital of Jiaxing University, The First People's Hospital of Huzhou, The Central Hospital of Lishui City, Lishui Country People's Hospital, Zhejiang University, Yuyao People's Hospital, The Third Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Cancer Hospital of Guangxi Medical University, Ningbo Medical Center Lihuili Hospital, Ruijin Hospital, Second Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Cancer Hospital, China, The Affiliated Tumor Hospital of Harbin Medical University, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Harbin Medical University, Xiangshan No.1 People' s Hospital, Zhejiang Province People's Hospital, Sir Run Run Shaw Hospital, Sun Yat-Sen University Cancer Center
- Responsible party
- Sponsor-investigator, Haixing Ju, MD, Zhejiang Cancer Hospital
- Investigators
- Haixing Ju, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709144
- Sponsor's protocol ID
- IRB-2024-935（IIT）
- Other IDs
- 2024IITZA001
- Acronym
- BLARCC
- Status last verified
- Aug 2024
- First submitted
- 18 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer(BLARCC): a Prospective, Multicenter Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT06709144
- Acronym / sponsor ID
- BLARCC / IRB-2024-935（IIT）
- Conditions
- Colon Cancer
- Keywords
- right side colon cancer, complete mesentery resection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 896 participants (estimated)
- Lead sponsor
- Haixing Ju, MDUniversity, hospital or other
- Collaborators
- Jiangxi Provincial Cancer Hospital, Jiangsu Cancer Institute & Hospital, Liaoning Cancer Hospital & Institute, The First Affiliated Hospital of Soochow University, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Shanxi Medical University, Shaoxing People's Hospital, Shaoxing Second Hospital, Ningbo No. 1 Hospital, Ningbo No.2 Hospital, Jinhua Central Hospital, Affiliated Hospital of Jiaxing University, The First People's Hospital of Huzhou, The Central Hospital of Lishui City, Lishui Country People's Hospital, Zhejiang University, Yuyao People's Hospital, The Third Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Cancer Hospital of Guangxi Medical University, Ningbo Medical Center Lihuili Hospital, Ruijin Hospital, Second Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Cancer Hospital, China, The Affiliated Tumor Hospital of Harbin Medical University, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Harbin Medical University, Xiangshan No.1 People' s Hospital, Zhejiang Province People's Hospital, Sir Run Run Shaw Hospital, Sun Yat-Sen University Cancer Center
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 29 Nov 2024 (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.
The study was conducted on patients with advanced right-sided colon cancer, and the clinical pathological and prognostic data of the patients were compared between the two groups of patients who were randomly divided into those undergoing SMV and SMA left resection, with the aim of resolving the controversy over the left resection boundary of CME/D3 lymph node dissection through this study, and to clarify whether SMA left resection is superior to SMV left resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group SMA | Experimental | Procedure: SMA lymph node dissectionThe lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA). |
| Group SMV | Active comparator | Procedure: SMV lymph node dissectionThe lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV) |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- right side colon cancer(The primary lesion is located in the ileocecal region, ascending colon, hepatic flexure of colon, or proximal transverse colon)
- T3-4 and/or N1-2M0
- Colonoscopy and pathological biopsy confirmed colon adenocarcinoma
Key exclusion criteria (9 listed)
- T1-2N0M0
- Cannot undergo curative resection
- Simultaneous multiple primary colorectal cancer or other diseases requiring segmental resection
- Distant metastasis
- Tumor invades surrounding organs, requiring joint organ resection
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 |
|---|---|---|
| SMA lymph node dissectionThe lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA) | Procedure or surgery | Group SMA |
| SMV lymph node dissectionThe lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV) | Procedure or surgery | Group SMV |
Primary outcome
3 year DFS
Time frame: 3 years
3 year disease free survival
1 secondary outcome
5 year OS
Time frame: 5 years
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 29 Nov 2024.
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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. This study is not recruiting at the moment.
Haixing Ju principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SMA lymph node dissection and SMV lymph node dissection in people with Colon Cancer, run by Haixing Ju, MD at 1 site 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year DFS (time frame: 3 years). 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 29 Nov 2024.