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Trial record 74 of 582 for:    Recruiting, Not yet recruiting, Available Studies | Superior

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

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ClinicalTrials.gov Identifier: NCT02547350
Recruitment Status : Not yet recruiting
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
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 ]


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

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
ClinicalTrials.gov 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
Carcinoma, Transitional Cell
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Pirarubicin
Epirubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action