Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036998
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2002-05-13
Brief Title:
Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
Sponsor:
Imunon
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast
Status:
UNKNOWN
Status Verified Date:
2004-07
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 Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature
PURPOSE Randomized phase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of surgery alone in treating women who have stage I or stage II breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of surgery alone in treating women who have stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Compare the safety and efficacy of preoperative focused microwave thermotherapy followed by surgery vs surgery alone in women with early-stage primary breast cancer
Compare the reduction of tumor cells at surgical margins and second incision rates in women treated with these regimens
Compare the percentage of pathological cell death in women treated with these regimens
Compare the amount of surgically removed breast and tumor tissue in women treated with these regimens
Compare the measurement of the extent tumor margins of the surgically removed breast and tumor tissue in women treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to tumor classification T1 vs T2 and participating center Patients are randomized to 1 of 2 treatment arms
Arm IPatients undergo ultrasound-guided placement of a microwave sensor and a temperature probe before or after compression of the breast and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue In the absence of undue heating of the skin a tumor temperature of 48-52 C is targeted and maintained for an equivalent thermal dose of 140-180 minutes
Within 60 days of thermotherapy patients undergo lumpectomy
Arm II Patients undergo lumpectomy only Patients are followed at 30 and 90 days after surgery and then at the discretion of the physician
PROJECTED ACCRUAL A total of 200-222 patients 100-111 per treatment arm will be accrued for this study
Compare the safety and efficacy of preoperative focused microwave thermotherapy followed by surgery vs surgery alone in women with early-stage primary breast cancer
Compare the reduction of tumor cells at surgical margins and second incision rates in women treated with these regimens
Compare the percentage of pathological cell death in women treated with these regimens
Compare the amount of surgically removed breast and tumor tissue in women treated with these regimens
Compare the measurement of the extent tumor margins of the surgically removed breast and tumor tissue in women treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to tumor classification T1 vs T2 and participating center Patients are randomized to 1 of 2 treatment arms
Arm IPatients undergo ultrasound-guided placement of a microwave sensor and a temperature probe before or after compression of the breast and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue In the absence of undue heating of the skin a tumor temperature of 48-52 C is targeted and maintained for an equivalent thermal dose of 140-180 minutes
Within 60 days of thermotherapy patients undergo lumpectomy
Arm II Patients undergo lumpectomy only Patients are followed at 30 and 90 days after surgery and then at the discretion of the physician
PROJECTED ACCRUAL A total of 200-222 patients 100-111 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| OU-09532 | None | None | None |
| CELSION-10200202 | None | None | None |