NCT00343356

Brief Summary

Biochemotherapy (combined immunotherapeutic drugs and chemotherapeutic drugs) has shown virtue than that use chemical or biological drugs alone in the treatment of some malignant tumor. Here we investigated the efficacy of sequential intravesical therapy with EPI and BCG to EPI or BCG alone in patients with transitional cell carcinoma of bladder cancer after surgical management.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 1996

Longer than P75 for phase_2

Status
completed

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 1, 1996

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2006

Completed
Last Updated

June 22, 2006

Status Verified

May 1, 1996

First QC Date

June 19, 2006

Last Update Submit

June 21, 2006

Conditions

Bladder Neoplasms

Keywords

Bladder neoplasm;Carcinoma;Epirubicin;BCG;Perfusion

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

Secondary Outcomes (1)

  • Side effect: Local toxicity was defined as the occurrence of culture proved bacterial cystitis, chemical or drug-induced cystitis, or other local side effects, such as hematuria, prostatitis or epididymiti

Interventions

TrementDRUG

Eligibility Criteria

Age26 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary single or multiple (more than 2 tumors) pTa to pT1 transitional cell carcinoma, solitary or multiple grade Ⅲ tumors and primary or concomitant carcinoma in situ of the bladder were included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Calais da Silva F, Denis L, Bono A, Bollack C, Bouffioux C. Intravesical chemoresection with 4'-epi-doxorubicin in patients with superficial bladder tumors. Eur Urol. 1988;14(3):207-9. doi: 10.1159/000472938.

    PMID: 3289935BACKGROUND

  • Rintala E, Jauhiainen K, Rajala P, Ruutu M, Kaasinen E, Alfthan O. Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for carcinoma in situ of the bladder. The Finnbladder Group. J Urol. 1995 Dec;154(6):2050-3.

    PMID: 7500456BACKGROUND

MeSH Terms

Conditions

Urinary Bladder NeoplasmsCarcinoma

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Zhang Xiangbo

    Lanzhou University Second Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 22, 2006

Study Start

June 1, 1996

Study Completion

July 1, 2003

Last Updated

June 22, 2006

Record last verified: 1996-05