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Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder

Primary Purpose

Bladder Neoplasms

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Trement
Sponsored by
LanZhou University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bladder Neoplasms focused on measuring Bladder neoplasm;, Carcinoma;, Epirubicin;, BCG;, Perfusion

Eligibility Criteria

26 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Previous radiotherapy, intravesicial or systemic chemotherapy within 3 months of the study, presence of a second primary malignancy and transitional cell carcinoma of the upper urinary tract or prostatic urethra, invasion of periurethral prostatic ducts, prostatic gland or stroma were exclusion criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Recurrence rate

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    June 19, 2006
    Last Updated
    June 21, 2006
    Sponsor
    LanZhou University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00343356
    Brief Title
    Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder
    Official Title
    Clinical Study of Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder After Surgical Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 1996
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    LanZhou University

    4. Oversight

    5. Study Description

    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.
    Detailed Description
    Methods From July 1996 to November 2003, a total of 138 cases of bladder cancer underwent TURBT or partial cystectomy were entered the trail. They were divided into 3 groups randomly: 1, EPI plus BCG; 2, use BCG alone; and 3, use EPI alone. All the patients have been followed up for 28-40 months after surgery (average time was 36 months), and the frequency of bacterial, chemical cystitis and other local side effects were also observed.Results After a median follow up of 36 months, the number of recurrences in group 1 was significantly reduced than group 2 and 3 (p<0.05 vs group 2 and 3, x2-test). The frequency of bacterial, chemical cystitis and other local side effects was similar in group 1 and 2, whereas significant severe side effect was found in group 3 (p<0.05 vs group 2 and 1, x2-test). Allergic reactions, including skin rash, were more frequent in group 3, and other systemic effects were more frequent in group 1. Conclusion Biochemotherapy by single dose EPI plus sequential BCG intravesical is markedly effect in preventing the recurrence of bladder cancer after surgical management. Its side effects are low. This method is of high clinical value.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Neoplasms
    Keywords
    Bladder neoplasm;, Carcinoma;, Epirubicin;, BCG;, Perfusion

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    138 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Trement
    Primary Outcome Measure Information:
    Title
    Recurrence rate
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Previous radiotherapy, intravesicial or systemic chemotherapy within 3 months of the study, presence of a second primary malignancy and transitional cell carcinoma of the upper urinary tract or prostatic urethra, invasion of periurethral prostatic ducts, prostatic gland or stroma were exclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhang Xiangbo
    Organizational Affiliation
    Second Hospital of Lanzhou University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    3289935
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    7500456
    Citation
    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.
    Results Reference
    background

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    Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder

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