NCT03209206

Brief Summary

The investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

3 years

First QC Date

June 30, 2017

Last Update Submit

December 21, 2017

Conditions

Urothelial Carcinoma

Keywords

Intravesical ChemotherapyDocetaxelRadical Nephroureterectomy

Outcome Measures

Primary Outcomes (1)

  • Recurrence in bladder

    Present of bladder recurrence after intervention in follow up cystoscopy or CT scan

    2years

Secondary Outcomes (3)

  • Incidence of Treatment-Emergent Adverse Events

    2years

  • Overall Survival

    2years

  • Time to recurrence

    2years

Study Arms (2)

Docetaxel bladder instillation arm

EXPERIMENTAL

After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline)

Drug: Docetaxel

Control arm

PLACEBO COMPARATOR

After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline)

Drug: Placebo Normal saline

Interventions

DocetaxelDRUG

Intravesical Instillation of Docetaxel (Docetaxel 75 mg diluted in 100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)

Also known as: Instillation docetaxel after radical nephroureterectomy
Docetaxel bladder instillation arm
Placebo Normal salineDRUG

Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)

Also known as: Instillation Normal saline after radical nephroureterectomy
Control arm

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Upper urinary tract urothelial cell carcinoma
  • Hb\>10g/dL, ANC \>1500mm3, Platelet \> 100K
  • Total bilirubin : 1.5 times lower than the normal upper limit
  • AST/ALT: 1.8 times lower than the normal upper limit
  • Alkaline phosphatase: 1.8 times lower than the normal upper limit

You may not qualify if:

  • Concomitant bladder tumor
  • Patients diagnosed with bladder cancer within the last 3 years
  • Previous history of hypersensitivity to Docetaxel
  • Neurogenic Bladder
  • Patients who received chemotherapy for cancer within the last 6 months
  • Patients with active disease not fit for this study
  • ANC \<1500mm3
  • Pregnant or lactating women
  • Patients with severe hepatic dysfunction
  • patients with severe renal impairment
  • patients with hypersensitivity to mannitol, paraplatin, platinum compounds
  • Patients with complications of infection
  • Patients suspected of having infectious fever

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (6)

  • Ito A, Shintaku I, Satoh M, Ioritani N, Aizawa M, Tochigi T, Kawamura S, Aoki H, Numata I, Takeda A, Namiki S, Namima T, Ikeda Y, Kambe K, Kyan A, Ueno S, Orikasa K, Katoh S, Adachi H, Tokuyama S, Ishidoya S, Yamaguchi T, Arai Y. Prospective randomized phase II trial of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma: the THP Monotherapy Study Group Trial. J Clin Oncol. 2013 Apr 10;31(11):1422-7. doi: 10.1200/JCO.2012.45.2128. Epub 2013 Mar 4.

    PMID: 23460707RESULT

  • Delto JC, Kobayashi T, Benson M, McKiernan J, Abate-Shen C. Preclinical analyses of intravesical chemotherapy for prevention of bladder cancer progression. Oncotarget. 2013 Feb;4(2):269-76. doi: 10.18632/oncotarget.852.

    PMID: 23563166RESULT

  • Wu P, Zhu G, Wei D, Liu S, Walsh K, Li D, Harron U, Wang X, Ma H, Wan B, Sun L, Yang Z, Wang J. Prophylactic intravesical chemotherapy decreases bladder tumor recurrence after nephroureterectomy for primary upper tract urothelial carcinoma: A systematic review and meta-analysis. J BUON. 2015 Sep-Oct;20(5):1229-38.

    PMID: 26537069RESULT

  • Laudano MA, Barlow LJ, Murphy AM, Petrylak DP, Desai M, Benson MC, McKiernan JM. Long-term clinical outcomes of a phase I trial of intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to standard intravesical therapy. Urology. 2010 Jan;75(1):134-7. doi: 10.1016/j.urology.2009.06.112. Epub 2009 Nov 13.

    PMID: 19913890RESULT

  • Lu S, Neoh KG, Kang ET, Mahendran R, Chiong E. Mucoadhesive polyacrylamide nanogel as a potential hydrophobic drug carrier for intravesical bladder cancer therapy. Eur J Pharm Sci. 2015 May 25;72:57-68. doi: 10.1016/j.ejps.2015.03.006. Epub 2015 Mar 13.

    PMID: 25772330RESULT

  • Barlow L, McKiernan J, Sawczuk I, Benson M. A single-institution experience with induction and maintenance intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to bacille Calmette-Guerin therapy. BJU Int. 2009 Oct;104(8):1098-102. doi: 10.1111/j.1464-410X.2009.08543.x. Epub 2009 Apr 15.

    PMID: 19389012RESULT

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Ja Hyeon Ku, M.D.,PH.D

    Seoul National University Hospital

    STUDY DIRECTOR

Central Study Contacts

Ja Hyeon Ku, M.D.,PH.D

CONTACT

+82-2-2072-0361randyku@hanmail.net

Bum Sik Tae, M.D

CONTACT

+82-10-9056-6618bumsik4ever@hanmail.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective Randomized Phase II Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD., PHD.

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 6, 2017

Study Start

June 28, 2017

Primary Completion

June 19, 2020

Study Completion

April 1, 2022

Last Updated

December 22, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)