Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 26 for:    upper tract urothelial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03230201
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Xuesong Li, Peking University First Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Recurrence Metastasis Upper Tract Urothelial Carcinoma Lymph Node Dissection Procedure: Lymph node dissection Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Lymph Node Dissection in the Management of High-risk Primary Upper Tract Urothelial Carcinoma Patients
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. overall survival [ Time Frame: three years after surgery ]

Secondary Outcome Measures :
  1. postoperative morbidity and mortality [ Time Frame: three years after surgery ]
  2. recurrence-free survival [ Time Frame: three years after surgery ]
  3. cancer specific survival [ Time Frame: three years after surgery ]
  4. event-free survival [ Time Frame: three years after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230201


Contacts
Layout table for location contacts
Contact: Xuesong Li, M.D. 8601083572481 pineneedle@sina.com

Locations
Layout table for location information
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Gengyan XIONG, M.D.         
Contact: Runqi GUO, M.D.         
Sponsors and Collaborators
Peking University First Hospital
Investigators
Layout table for investigator information
Study Chair: Liqun Zhou, M.D. Peking University First Hosipital

Layout table for additonal information
Responsible Party: Xuesong Li, Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03230201     History of Changes
Other Study ID Numbers: IUPU-16-UTUC-3
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Transitional Cell
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Disease Attributes