Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023842
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2001-09-13
Brief Title:
BCG With or Without Mitomycin in Treating Patients With Bladder Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase II Trial of Sequential Chemo-Immunotherapy Versus Immunotherapy Alone in Carcinoma in Situ of the Urinary Bladder
Status:
COMPLETED
Status Verified Date:
2012-09
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:
RATIONALE Biological therapies such as BCG use different ways to stimulate the immune system and stop tumor cells from growing Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with biological therapy may kill more tumor cells It is not yet known if BCG is more effective with or without mitomycin
PURPOSE Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with that of BCG alone in treating patients who have bladder cancer
PURPOSE Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with that of BCG alone in treating patients who have bladder cancer
Detailed Description:
OBJECTIVES
Compare the complete response rate of patients with carcinoma in situ of the bladder treated with adjuvant intravesical BCG with or without intravesical mitomycin following transurethral resection
Compare the disease-free interval and type of recurrence after complete response in patients treated with these regimens
Compare the side effects of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to one of two treatment arms
Arm I
Induction therapy Patients receive intravesical mitomycin over 1 hour once weekly on weeks 1-6 and intravesical BCG once weekly on weeks 7-12 Patients with visible lesions or disease recurrence or progression undergo transurethral resection TUR during weeks 16-18 and receive one additional course of intravesical therapy
Maintenance therapyPatients with a complete response after either course of induction therapy proceed to maintenance therapy comprising intravesical mitomycin once on week 1 and intravesical BCG once weekly on weeks 2 and 3 Maintenance therapy repeats every 6 months through year 3
Arm II
Induction therapyPatients receive intravesical BCG once weekly on weeks 1-6 and 10-12 Patients with visible lesions or disease recurrence or progression undergo transurethral resection TUR during weeks 16-18 and receive one additional course of intravesical therapy
Maintenance therapy Patients with a complete response after either course of induction therapy receive maintenance therapy comprising intravesical BCG once weekly on weeks 1-3 Maintenance therapy repeats every 6 months through year 3
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 84-126 patients 42-63 per treatment arm will be accrued for this study within 35 years
Compare the complete response rate of patients with carcinoma in situ of the bladder treated with adjuvant intravesical BCG with or without intravesical mitomycin following transurethral resection
Compare the disease-free interval and type of recurrence after complete response in patients treated with these regimens
Compare the side effects of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to one of two treatment arms
Arm I
Induction therapy Patients receive intravesical mitomycin over 1 hour once weekly on weeks 1-6 and intravesical BCG once weekly on weeks 7-12 Patients with visible lesions or disease recurrence or progression undergo transurethral resection TUR during weeks 16-18 and receive one additional course of intravesical therapy
Maintenance therapyPatients with a complete response after either course of induction therapy proceed to maintenance therapy comprising intravesical mitomycin once on week 1 and intravesical BCG once weekly on weeks 2 and 3 Maintenance therapy repeats every 6 months through year 3
Arm II
Induction therapyPatients receive intravesical BCG once weekly on weeks 1-6 and 10-12 Patients with visible lesions or disease recurrence or progression undergo transurethral resection TUR during weeks 16-18 and receive one additional course of intravesical therapy
Maintenance therapy Patients with a complete response after either course of induction therapy receive maintenance therapy comprising intravesical BCG once weekly on weeks 1-3 Maintenance therapy repeats every 6 months through year 3
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 84-126 patients 42-63 per treatment arm will be accrued for this study within 35 years
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 |
|---|---|---|---|
| NCRI-EORTC-30993 | None | None | None |
| EORTC-30993 | None | None | None |
| AURO-EORTC-30993 | None | None | None |
| FINNBLADDER-EORTC-30993 | None | None | None |
| GAUO-EORTC-30993 | None | None | None |
| SEUG-EORTC-30993 | None | None | None |
| UKCCCR-EORTC-30993 | None | None | None |