Lymph Node DissectionPhase 2NCT03474926
Prognostic Value of Lymph Node Dissection in Patients With Transitional Cell Carcinoma of the Upper Urinary Tract
A Phase 2 study testing Routine Template-based lymphadenectomy and LND only for lymph nodes enlargement found in preoperative image or during surgery in people with Lymph Node Dissection, run by RenJi Hospital at 2 sites in China.
Trial summary
Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Lymph Node Dissection
- What is being tested?
- Routine Template-based lymphadenectomy and LND only for lymph nodes enlargement found in preoperative image or during surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 2 sitesChina
- Study dates
- 22 Feb 2018to 22 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinically diagnosed with upper tract urothelial carcinoma
- have no distant metastasis
- have an Eastern Cooperative Oncology Group (ECOG) score 0 to 2
- expected to receive radical nephroureterectomy
Who cannot join
- a prior history of bladder cancer
- administration of neoadjuvant chemotherapy
- deny to receive long term follow-up
- patients with contralateral UTUCs
- patients with synchronous muscle invasive bladder cancer
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking University First Hospital
Beijin, Beijin, 100034
Xuesong Li, M.D
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200123
Jiwei Huang, M.D
About this study
Official title: Prospective Randomized Phase II Trial: Comparing the Prognostic Value of Routine Lymphadenectomy Versus Lymphadenectomy Only for Lymph Nodes Enlargement Found in Preoperative Imaging or During Surgery Undergoing Nephroureterectomy in Patients With Primary Upper Tract Urothelial Carcinoma
Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.
- Conditions
- Lymph Node Dissection
- Being tested
- Routine Template-based lymphadenectomy, LND only for lymph nodes enlargement found in preoperative image or during surgery
- Keywords
- urothelial cancer, nephroureterectomy, Upper urinary tract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Template-based lymphadenectomyProcedure or surgery
Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled "en bloc" with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue.
LND only for lymph nodes enlargement found in preoperative image or during surgeryProcedure or surgery
LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (e.g. CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery
| Study group | Role | What they receive |
|---|---|---|
| Routine lymph node dissection (LND) during nephroureterectomy | Experimental | Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled "en bloc" with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue. Receives: Procedure: Routine Template-based lymphadenectomy |
| LND for lymph nodes enlargement found before or during surgery | Active comparator | LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery. Receives: Procedure: LND only for lymph nodes enlargement found in preoperative image or during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease free survival rate in the 36 month following nephroureterectomy
Measured: 36 month
Secondary outcomes (4)
Cancer specific survival
Cancer specific survival rate in the 36 month following nephroureterectomy
Measured: 36 month
Overall survival
Overall survival rate in the 36 month following nephroureterectomy
Measured: 36 month
The recurrence rate of bladder cancer in the 36 month following nephroureterectomy
The recurrence rate of bladder cancer in the 36 month following nephroureterectomy
Measured: 36 month
Perioperative complications rate
Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification
Measured: 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start22 Feb 2018
- Primary completion22 Feb 2023 (estimated)
- Study completion22 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node DissectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
- Investigators
- Wei Xue, M.D, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.Liqun Zhou, M.D, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474926
- Sponsor's protocol ID
- UTUC-LND collaboration 1
- Status last verified
- May 2018
- First submitted
- 27 Feb 2018
- Last updated
- 22 May 2018
- 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 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Phase II Trial: Comparing the Prognostic Value of Routine Lymphadenectomy Versus Lymphadenectomy Only for Lymph Nodes Enlargement Found in Preoperative Imaging or During Surgery Undergoing Nephroureterectomy in Patients With Primary Upper Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT03474926
- Acronym / sponsor ID
- UTUC-LND collaboration 1
- Conditions
- Lymph Node Dissection
- Keywords
- urothelial cancer, nephroureterectomy, Upper urinary tract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 22 Feb 2023 (estimated)
- Study completion
- 22 Feb 2023 (estimated)
- First posted
- 23 Mar 2018 (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.
Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine lymph node dissection (LND) during nephroureterectomy | Experimental | Procedure: Routine Template-based lymphadenectomyTemplate-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled "en bloc" with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue. |
| LND for lymph nodes enlargement found before or during surgery | Active comparator | Procedure: LND only for lymph nodes enlargement found in preoperative image or during surgeryLND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- clinically diagnosed with upper tract urothelial carcinoma
- have no distant metastasis
- have an Eastern Cooperative Oncology Group (ECOG) score 0 to 2
- expected to receive radical nephroureterectomy
Key exclusion criteria (5 listed)
- a prior history of bladder cancer
- administration of neoadjuvant chemotherapy
- deny to receive long term follow-up
- patients with contralateral UTUCs
- patients with synchronous muscle invasive bladder cancer
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 |
|---|---|---|
| Routine Template-based lymphadenectomyTemplate-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled "en bloc" with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue. | Procedure or surgery | Routine lymph node dissection (LND) during nephroureterectomy |
| LND only for lymph nodes enlargement found in preoperative image or during surgeryLND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (e.g. CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery | Procedure or surgery | LND for lymph nodes enlargement found before or during surgery |
Primary outcome
Disease free survival
Time frame: 36 month
Disease free survival rate in the 36 month following nephroureterectomy
4 secondary outcomes
Cancer specific survival
Time frame: 36 month
Overall survival
Time frame: 36 month
The recurrence rate of bladder cancer in the 36 month following nephroureterectomy
Time frame: 36 month
Perioperative complications rate
Time frame: 90 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
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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.
Wei Xue, M.D principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Liqun Zhou, M.D principal investigator
Peking University First Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Routine Template-based lymphadenectomy and LND only for lymph nodes enlargement found in preoperative image or during surgery in people with Lymph Node Dissection, run by RenJi Hospital at 2 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jiwei huang, M.D. (8613651682825, huangjiwei@renji.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: 36 month). 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 22 May 2018.