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Trial record 14 of 26 for:    upper tract urothelial

Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT03030157
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Shanghai Pudong Hospital
Shanghai Pudong New Area Gongli Hospital
Information provided by (Responsible Party):
Yiran Huang, RenJi Hospital

Brief Summary:
Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.

Condition or disease Intervention/treatment Phase
Intravesical Instillation Drug: pirarubicin(THP) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Long-term Intravesical Instillation of pirarubicin(THP)
A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The first instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.
Drug: pirarubicin(THP)
Active Comparator: Single Intravesical Instillation of pirarubicin
A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.
Drug: pirarubicin(THP)



Primary Outcome Measures :
  1. The incidence of bladder cancer in the first 12 month following nephroureterectomy [ Time Frame: 12 month ]
    Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 day, 1 month and 12 month ]
  2. questionnaire for quality of life [ Time Frame: baseline, 1 month and 12 month ]
    e.g QLQ C-30

  3. progression-free survival [ Time Frame: 12 month ]
    progression-free survival

  4. cancer-specific survival [ Time Frame: 12 month ]
    cancer-specific survival

  5. overall survival [ Time Frame: 12 month ]
    overall survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically diagnosed with upper tract urothelial carcinoma
  • have no distant metastasis
  • have an ECOG 0 to 2
  • expected to receive radical nephroureterectomy

Exclusion Criteria:

  • a prior history of bladder or synchronous bladder cancer
  • administration of neoadjuvant chemotherapy
  • the presence of severe complications
  • deny to receive cytoscopy
  • patients with advanced stage (T4)
  • patients with contralateral UTUCs

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): NCT03030157


Contacts
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Contact: jiwei huang 8613651682825 jiweihuang@outlook.com

Locations
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China, Shanghai
Renji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: jiwei huang, M.D    8613651682825    jiweihuang@outlook.com   
Contact: jin zhang    86-21-68383776    zhangjin@renji.com   
Sponsors and Collaborators
RenJi Hospital
Shanghai Pudong Hospital
Shanghai Pudong New Area Gongli Hospital

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Responsible Party: Yiran Huang, Director of Urology department in Renji Hospital, RenJi Hospital
ClinicalTrials.gov Identifier: NCT03030157     History of Changes
Other Study ID Numbers: RenJiH-PDU Trial
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Keywords provided by Yiran Huang, RenJi Hospital:
urothelial cancer
bladder cancer
nephroureterectomy
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Recurrence
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Pirarubicin
Doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action