Lymph Node Dissection in High-risk UTUC(Upper Tract Urothelial Carcinoma) (UTUC)

August 5, 2017 updated by: Xuesong Li, Peking University First Hospital

Impact of Lymph Node Dissection in the Management of High-risk Primary Upper Tract Urothelial Carcinoma Patients

This clinical trial is designed to evaluate the role of lymph node dissection in the prevention of recurrence and metastasis after radical nephroureterectomy for high-risk primary upper tract urothelial carcinoma (UTUC) patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

INTRODUCTION Upper tract urothelial carcinomas (UTUC) are relatively uncommon compared to bladder cancer and account for only 5-10% of urothelial carcinomas, with an estimated annual incidence in Western countries of

~2 cases per 100,000 inhabitants. The therapeutic role of regional lymph node dissection (LND) for patients with UTUC remains undetermined. Most reports have supported its staging benefit in which patients with no lymph node metastases (pN0) and those with pathological node metastasis (pN+) are stratified from those without LND (pNx). However, the therapeutic benefit of LND remains controversial. This discrepancy might be attributed to two factors. First, there remains a lack of standardization in the extent of LND. Kondo T et al and Matin SF et al previously reported the primary sites of lymphatic metastases from a mapping study, and then determined the anatomical extent of regional lymph nodes. Second, all results reported so far have been, to the best of our knowledge, derived from retrospective studies. Thus, the current guideline recommends LND for invasive UTUC on the basis of insufficient evidence. AIM OF THE WORK This clinical trial is designed to evaluate the role of lymph node dissection in the prevention of recurrence and metastasis after radical nephroureterectomy for high-risk primary upper tract urothelial carcinoma (UTUC) patients. PATIENTS AND METHODS Patients Type of the study: A randomized controlled trial (RCT), phase II. Study locality: Department of Urology, Peking University First Hospital. Institute of Urology, Peking University. National Urological Cancer Center, Beijing, China. Study design: Patients who was ready to receive nephroureterectomy for high-risk primary UTUC will be prospectively randomized into two groups using excel software by random table function. I. Group 1: will receive LND during radical nephroureterectomy. II. Group 2: do not receive LND during surgery.

Inclusion Criteria:

I. Suspected high-risk UTUC patients without metastases in their preoperative radiological imaging (cN0M0).II. Suspected high-risk UTUC patients without history of bladder tumor.

III. Suspected high-risk UTUC patients without synchronous bladder tumor. IV. Suspected high-risk UTUC patients without contralateral UTUCs.

Exclusion criteria:

I. Patients with significant metastases in their preoperative radiological imaging.

II. Patients with history of bladder tumor. III. Patients with synchronous bladder tumor. IV. Patients with contralateral UTUCs. V. Patients with advanced stage (T4). VI. Patients with other malignant tumors. Methods Intervention Patients who sign an informed consent for agreement to participate will be randomly allocated into one of the two groups using excel software by random table function at the day of nephroureterectomy. In group 1, patients will receive LND during radical nephroureterectomy. While for patients in group 2, no LND will be received. All data will be prospectively maintained and include patients' demographics, preoperative laboratory parameters, operative details and postoperative complications Follow up The scheduled follow up will be according to the EAU guidelines (Rouprêt et al., 2015) by scheduling a urine cytology and cystoscopy at 3 months then yearly while CT urography every year for non-invasive tumors and every 6 months over 2 years and then yearly for invasive tumors. All chemotherapy-related complications will be reported. Outcome and end-point The primary outcome of the study is to determine the overall survival (OS). The secondary outcome is to determine the adverse events postoperative morbidity, mortality and other survival (RFS, CSS, EFS) of patients with high-risk UTUC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Gengyan XIONG, M.D.
        • Contact:
          • Runqi GUO, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • I. Suspected high-risk UTUC patients without metastases in their preoperative radiological imaging (cN0M0).II. Suspected high-risk UTUC patients without history of bladder tumor.

III. Suspected high-risk UTUC patients without synchronous bladder tumor. IV. Suspected high-risk UTUC patients without contralateral UTUCs

Exclusion Criteria:

  • I. Patients with significant metastases in their preoperative radiological imaging.

II. Patients with history of bladder tumor. III. Patients with synchronous bladder tumor. IV. Patients with contralateral UTUCs. V. Patients with advanced stage (T4). VI. Patients with other malignant tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Blank control
do not receive Lymph node dissection during surgery.
Experimental: Lymph node dissection
will receive Lymph node dissection during radical nephroureterectomy.
Procedure: Lymph node dissection
Lymph node dissection during radical nephroureterectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
overall survival
Time Frame: three years after surgery
three years after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
postoperative morbidity and mortality
Time Frame: three years after surgery
three years after surgery
recurrence-free survival
Time Frame: three years after surgery
three years after surgery
cancer specific survival
Time Frame: three years after surgery
three years after surgery
event-free survival
Time Frame: three years after surgery
three years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Liqun Zhou, M.D., Peking University First Hosipital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IUPU-16-UTUC-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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