Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003725
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
Sponsor:
Anthra Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study of a Single Adjunctive Instillation of Intravesical AD 32 N-Trifluoroacetyladriamycin-14-valerate Versus No Adjunctive Therapy Immediately Following Transurethral Resection in Patients With Multiple Superficial TaT1 Bladder Tumors
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether transurethral resection plus AD 32 is more effective than transurethral resection alone for bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer
Detailed Description:
OBJECTIVES I Assess the efficacy of adjuvant AD 32 following complete transurethral resection versus transurethral resection alone in patients with newly diagnosed or recurrent superficial transitional cell carcinoma of the bladder II Assess the toxicity of AD 32 in these patients
OUTLINE This is an open label randomized multicenter study Patients are randomized to receive surgery with AD 32 or surgery alone Arm I Patients undergo surgery to remove bladder tumors AD 32 is administered by catheter into the bladder within 2-24 hours after surgery Patients must hold the AD 32 liquid in the bladder for 90 minutes Arm II Patients undergo only surgery to remove bladder tumors Patients with T1 or Tis disease may receive BCG therapy once weekly for 6 weeks followed by 6 weeks of rest Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL This study will accrue approximately 300 patients
OUTLINE This is an open label randomized multicenter study Patients are randomized to receive surgery with AD 32 or surgery alone Arm I Patients undergo surgery to remove bladder tumors AD 32 is administered by catheter into the bladder within 2-24 hours after surgery Patients must hold the AD 32 liquid in the bladder for 90 minutes Arm II Patients undergo only surgery to remove bladder tumors Patients with T1 or Tis disease may receive BCG therapy once weekly for 6 weeks followed by 6 weeks of rest Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL This study will accrue approximately 300 patients
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 |
|---|---|---|---|
| ANTHRA-A9601 | None | None | None |