Colorectal NeoplasmsFLORA-01NCT05730595
Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer
A study testing lymph node dissection in people with Colorectal Neoplasms and Fluorescence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 19 sites in China.
Trial summary
To explore the short-term and long-term outcomes of fluorescence laparoscopic navigation D2 lymph node dissection for colorectal cancer surgery by comparing it with D3 lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Fluorescence, Lymph Node Excision
- What is being tested?
- lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 19 sitesChina
- Study dates
- 1 Sep 2023to 1 Jun 2027
- Phase
- Interventional
- 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
- Participants are aged 18-75;
- Colonoscopy biopsy confirms colorectal adenocarcinoma;
- Colonoscopy shows that the lower edge of the tumor is located more than 10 cm from the margin or the tumor is located in the upper rectum and sigmoid colon by imaging diagnosis;
- The tumor is staged cT1-4aNxM0 by preoperative imaging;
- Participants have no local complications before surgery.
Who cannot join
- Previous history of malignant colorectal tumor;
- Multiple primary colorectal tumors;
- Preoperative imaging reveals suspicious positive lymph nodes in the submesenteric artery root region (area 253);
- Patients undergoing neoadjuvant therapy before surgery;
- With contraindications to laparoscopic surgery;
- Histoty of multiple abdominal and pelvic surgery or extensive abdominal adhesions;
Show all 10Show fewer
- Other malignancies were diagnosed within the past 5 years;
- History of severe mental illness;
- Pregnant or lactating women;
- With uncontrolled infection before surgery.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Binzhou Medical University
Binzhou, Shandong, 256603
Hong Jiang, Dr., 155 6436 6177
The First Hospital of Jilin University
Changchun, Jilin, 130021
Quan Wang, Dr., 13944810508
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Chengdu, 610500
Jiangwei Xiao, Dr., 17311394528
Fujian Province Tumor Hospital
Fuzhou, Fujian, 350014
Chunkang Yang, Dr., 13509333116
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Dechang Diao
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510320
Deqing Wu, Dr., 13902301120
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Haijun Deng, Dr., 13189096629
The Second Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, 150001
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Hanhui Yao, Dr., 13505698955
The second People's Hospital of Yunnan Province
Kunming, Yunnan, 650021
Bo Li, Dr., 137 0847 2035
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, 330029
Bo Yi, Dr., 13517007527
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Hao Wang, Dr., 18602513286
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Guoxiang Cai, Dr., 13611831623
Shengjing Hospital
Shenyang, Liaoning, 110004
Hong Zhang, Dr., 18940257919
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Haiyi Liu, Dr., 15802513619
Qinghai University Affiliated Hospital
Xining, Qinghai, 810001
Su Yan, Dr., 13519768807
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Miao Wu, Dr., 13990905852
About this study
Official title: A Randomized Controlled Trial of Fluorescence Laparoscopic Navigation of the Extent of Lymph Node Dissection for High Rectal Cancer and Sigmoid Colon Cancer
To explore the short-term and long-term outcomes of fluorescence laparoscopic navigation D2 lymph node dissection for colorectal cancer surgery by comparing it with D3 lymph node dissection.
Read the detailed description
Lymph node metastasis is the most common metastatic mechanisms for colorectal cancer. Therefore, regional lymph node dissection is the key part in radical surgery for colorectal cancer. In patients who have developed lymph node metastases, inadequate lymph node dissection will promote tumor recurrence. In patients who do not develop lymph node metastases, excessive lymph node dissection not only does not improve the patient's prognosis, but also increases surgical trauma and destroys the antitumor effect of the lymphoid immune system. There is still some controversy over whether to choose D3 lymph node dissection or D2 lymph node dissection for rectal and sigmoid cancer. Fluorescence laparoscopic navigation techniques can guide lymph node dissection by visualizing lymph nodes more clearly during surgery.
This study will compare the short-term and long-term oncological outcomes between fluorescence laparoscopic navigation D2 and D3 lymph node dissection by conducting a randomized controlled trial.
- Conditions
- Colorectal Neoplasms, Fluorescence, Lymph Node Excision
- Being tested
- lymph node dissection
- Keywords
- Colorectal cancer, Fluorescence laparoscopic navigation, Lymph node dissection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymph node dissectionProcedure or surgery
Also called Fluorescence-guided laparoscopic surgery, Radical operation for rectal cancer and sigmoid Cancer
The extent of lymph node dissection varies between groups
| Study group | Role | What they receive |
|---|---|---|
| D2 lymph node dissection | Experimental | The D2 lymph node region are dissected. And 1-3 lymph nodes of the D2 region will be selected for intraoperative frozen section. If no lymph node metastasis is found in freezing, the D3 region lymph nodes in the root of the submesenteric artery were preserved. Receives: Procedure: lymph node dissection |
| D3 lymph node dissection | Active comparator | Thorough dissection of lymph nodes in the D3 region. Receives: Procedure: lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.
Measured: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 36 months.
Overall survival
Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.
Measured: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months.
Secondary outcomes (5)
The number of lymph node resection
The number of lymph nodes removed during surgery, which is obtained by postoperative pathological results
Measured: Until the pathological result is available , an average of 14 days.
Blood loss
Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).
Measured: Until the end of the operation, an average of 8 hours.
Complications
Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.
Measured: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Hospital stay after surgery
Hospital stay after surgery is defined as the length of time from the end of surgery
Measured: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Function score
Function score includes International Prostate Symptom Score, low anterior resection syndrome score and International Index of Erectile Function-5 score, which are used for assess the physical function.
Measured: Until one year after the patient's surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Fujian Province Tumor Hospital, Guangdong Provincial People's Hospital, Shengjing Hospital, Affiliated Hospital of Qinghai University, Hebei Medical University Fourth Hospital, The Second Affiliated Hospital of Harbin Medical University, Jiangxi Provincial Cancer Hospital, The First Hospital of Jilin University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shanxi Province Cancer Hospital, Nanfang Hospital, Southern Medical University, Second People's Hospital of Yunnan Province, Binzhou Medical University, The First Affiliated Hospital of University of Science and Technology of China, First Affiliated Hospital of Chengdu Medical College, The Second People's Hospital of Yibin, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Principal investigator, Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730595
- Sponsor's protocol ID
- NCC20231
- Acronym
- FLORA-01
- Status last verified
- Aug 2023
- First submitted
- 7 Feb 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Fluorescence Laparoscopic Navigation of the Extent of Lymph Node Dissection for High Rectal Cancer and Sigmoid Colon Cancer
- ClinicalTrials.gov ID
- NCT05730595
- Acronym / sponsor ID
- FLORA-01 / NCC20231
- Conditions
- Colorectal Neoplasms, Fluorescence, Lymph Node Excision
- Keywords
- Colorectal cancer, Fluorescence laparoscopic navigation, Lymph node dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Fudan University, Fujian Province Tumor Hospital, Guangdong Provincial People's Hospital, Shengjing Hospital, Affiliated Hospital of Qinghai University, Hebei Medical University Fourth Hospital, The Second Affiliated Hospital of Harbin Medical University, Jiangxi Provincial Cancer Hospital, The First Hospital of Jilin University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shanxi Province Cancer Hospital, Nanfang Hospital, Southern Medical University, Second People's Hospital of Yunnan Province, Binzhou Medical University, The First Affiliated Hospital of University of Science and Technology of China, First Affiliated Hospital of Chengdu Medical College, The Second People's Hospital of Yibin, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 Feb 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.
To explore the short-term and long-term outcomes of fluorescence laparoscopic navigation D2 lymph node dissection for colorectal cancer surgery by comparing it with D3 lymph node dissection.
Detailed description
Lymph node metastasis is the most common metastatic mechanisms for colorectal cancer. Therefore, regional lymph node dissection is the key part in radical surgery for colorectal cancer. In patients who have developed lymph node metastases, inadequate lymph node dissection will promote tumor recurrence. In patients who do not develop lymph node metastases, excessive lymph node dissection not only does not improve the patient's prognosis, but also increases surgical trauma and destroys the antitumor effect of the lymphoid immune system. There is still some controversy over whether to choose D3 lymph node dissection or D2 lymph node dissection for rectal and sigmoid cancer. Fluorescence laparoscopic navigation techniques can guide lymph node dissection by visualizing lymph nodes more clearly during surgery.
This study will compare the short-term and long-term oncological outcomes between fluorescence laparoscopic navigation D2 and D3 lymph node dissection by conducting a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 lymph node dissection | Experimental | Procedure: lymph node dissectionThe D2 lymph node region are dissected. And 1-3 lymph nodes of the D2 region will be selected for intraoperative frozen section. If no lymph node metastasis is found in freezing, the D3 region lymph nodes in the root of the submesenteric artery were preserved. |
| D3 lymph node dissection | Active comparator | Procedure: lymph node dissectionThorough dissection of lymph nodes in the D3 region. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants are aged 18-75;
- Colonoscopy biopsy confirms colorectal adenocarcinoma;
- Colonoscopy shows that the lower edge of the tumor is located more than 10 cm from the margin or the tumor is located in the upper rectum and sigmoid colon by imaging diagnosis;
- The tumor is staged cT1-4aNxM0 by preoperative imaging;
- Participants have no local complications before surgery.
Key exclusion criteria (10 listed)
- Previous history of malignant colorectal tumor;
- Multiple primary colorectal tumors;
- Preoperative imaging reveals suspicious positive lymph nodes in the submesenteric artery root region (area 253);
- Patients undergoing neoadjuvant therapy before surgery;
- With contraindications to laparoscopic surgery;
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 |
|---|---|---|
| lymph node dissectionAlso: Fluorescence-guided laparoscopic surgery, Radical operation for rectal cancer and sigmoid CancerThe extent of lymph node dissection varies between groups | Procedure or surgery | D2 lymph node dissection, D3 lymph node dissection |
Primary outcome
Disease-free survival
Time frame: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 36 months.
Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.
Overall survival
Time frame: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months.
Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.
5 secondary outcomes
The number of lymph node resection
Time frame: Until the pathological result is available , an average of 14 days.
Blood loss
Time frame: Until the end of the operation, an average of 8 hours.
Complications
Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Hospital stay after surgery
Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Function score
Time frame: Until one year after the patient's surgery
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 Aug 2023.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymph node dissection in people with Colorectal Neoplasms and Fluorescence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 19 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 29 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 19 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.
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 Jianqiang Tang, Dr. (+8613661090036, doc_tjq@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 36 months.). The study lists 2 primary outcomes in all. 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 Aug 2023.