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
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.
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. ;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00536588 -
A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816)
|
Phase 1 | |
Recruiting |
NCT00872495 -
Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
|
||
Terminated |
NCT02900248 -
CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
|
||
Completed |
NCT00406068 -
Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
|
Phase 2/Phase 3 | |
Completed |
NCT00077688 -
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
|
Phase 2 | |
Completed |
NCT00462488 -
Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ
|
Phase 2 | |
Completed |
NCT00001381 -
A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
|
Phase 1 | |
Terminated |
NCT00050687 -
Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
|
Phase 1/Phase 2 | |
Completed |
NCT01090388 -
Bladder Cancer Patient-Reported Outcomes
|
N/A | |
Completed |
NCT00141531 -
Phase II Trial of EOquin in High-risk Superficial Bladder Cancer
|
Phase 2 | |
Completed |
NCT00315237 -
Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract
|
Phase 3 | |
Completed |
NCT00491114 -
Intravesical Chemotherapy Treatment of Superficial Bladder Cancer
|
Phase 2 | |
Completed |
NCT00393809 -
Safety and Proof of Concept Study of Intravesical DTA-H19 in Patients With Superficial Bladder Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00101608 -
Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
|
Phase 2 | |
Terminated |
NCT00191477 -
Instillation of Gemcitabine in Patients With Superficial Bladder Cancer
|
Phase 3 | |
Recruiting |
NCT05072600 -
Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer
|
Phase 2 | |
Completed |
NCT00963404 -
Image-Guided Tumorboost of Bladder Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00109655 -
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
|
Phase 1 | |
Completed |
NCT00188695 -
Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00871754 -
Molecular Analysis Of Bladder Cancer
|