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

Bladder Neoplasms Clinical Trial

Official title:

Clinical Study of Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder After Surgical Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343356
• Other study ID #: LanZhou University
• Secondary ID: 1996L01936
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2006
• Last updated: June 21, 2006
• Start date: June 1996
• Est. completion date: July 2003

Study information

• Verified date: May 1996
• Source: LanZhou University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 26 Years to 72 Years

Eligibility

Inclusion Criteria:

• primary single or multiple (more than 2 tumors) pTa to pT1 transitional cell carcinoma, solitary or multiple grade ? 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bladder Neoplasms
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms

Intervention

Drug:
• Trement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LanZhou University

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate
Secondary	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