Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343356
Status:
COMPLETED
Last Update Posted:
2006-06-22
First Post:
2006-06-19
Brief Title:
Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder
Sponsor:
LanZhou University
Organization:
LanZhou University
Study Overview
Official Title:
Clinical Study of Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder After Surgical Management
Status:
COMPLETED
Status Verified Date:
1996-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 observedResults After a median follow up of 36 months the number of recurrences in group 1 was significantly reduced than group 2 and 3 p005 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 p005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1996L01936 | None | None | None |