Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066872
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2003-08-06
Brief Title:
Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
Sponsor:
Queens Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5 Cream for Nodular and Superficial Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-09
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 imiquimod use different ways to stimulate the immune system and stop cancer cells from growing It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer
PURPOSE This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer
PURPOSE This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer
Detailed Description:
OBJECTIVES
Compare the rate of local recurrence at 3 years in patients with nodular or superficial basal cell skin cancer treated with imiquimod 5 cream vs excisional surgery
Compare recurrence at 6 months and 1 2 and 5 years in patients treated with these regimens
Compare the time to first recurrence in patients treated with these regimens
Compare the aesthetic appearance of lesion sites in patients treated with these regimens
Compare pain in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and lesion type nodular vs superficial Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive topical imiquimod to a single lesion once daily for 6 weeks for a superficial lesion or 12 weeks for a nodular lesion Patients with early treatment failure or recurrence are offered surgical excision
Arm II Patients undergo surgical excision Patients are followed at 6 12 and 18 weeks every 6 months for 1 year annually for 2 years and then at 5 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study within 18 months
Compare the rate of local recurrence at 3 years in patients with nodular or superficial basal cell skin cancer treated with imiquimod 5 cream vs excisional surgery
Compare recurrence at 6 months and 1 2 and 5 years in patients treated with these regimens
Compare the time to first recurrence in patients treated with these regimens
Compare the aesthetic appearance of lesion sites in patients treated with these regimens
Compare pain in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and lesion type nodular vs superficial Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive topical imiquimod to a single lesion once daily for 6 weeks for a superficial lesion or 12 weeks for a nodular lesion Patients with early treatment failure or recurrence are offered surgical excision
Arm II Patients undergo surgical excision Patients are followed at 6 12 and 18 weeks every 6 months for 1 year annually for 2 years and then at 5 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study within 18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20205 | None | None | None |
| CRUK-LON-SINS-C7484A2869 | None | None | None |