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Trial record 15 of 26 for:    upper tract urothelial

Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas

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. Identifier: NCT02547350
Recruitment Status : Not yet recruiting
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Information provided by (Responsible Party):
Xuesong Li, Peking University First Hospital

Brief Summary:
The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).

Condition or disease Intervention/treatment Phase
Upper Tract Urothelial Carcinoma Bladder Recurrence Drug: pharmorubicin or pirarubicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : September 2015
Estimated Primary Completion Date : December 2020

Arm Intervention/treatment
No Intervention: Blank control
do not use prophylactic intravesical chemotherapy
Experimental: single intravesical instillation
intravesical instillation within 24 hours postoperatively
Drug: pharmorubicin or pirarubicin
pharmorubicin 50mg pirarubicin 30mg

Experimental: multiple intravesical instillation
intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months
Drug: pharmorubicin or pirarubicin
pharmorubicin 50mg pirarubicin 30mg

Primary Outcome Measures :
  1. intravesical recurrence-free survival [ Time Frame: two years after surgery ]

Secondary Outcome Measures :
  1. cancer-specific survival [ Time Frame: two years after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients who were clinically diagnosed with UTUC
  2. Treated with radical nephroureterectomy

Exclusion Criteria:

  1. Distant metastasis
  2. Prior history of bladder or synchronous bladder cancer
  3. Administration of neoadjuvant chemotherapy
  4. Presence of severe complications.

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Responsible Party: Xuesong Li, professor, Peking University First Hospital Identifier: NCT02547350     History of Changes
Other Study ID Numbers: PIC-UTUC
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action