Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036985
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2002-05-13
Brief Title:
Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer
Sponsor:
Imunon
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Pivotal Clinical Trial To Assess The Efficacy Of Pre-operative Focused Microwave Thermotherapy Treatment Combined With Pre-operative Chemotherapy For Cytoreduction Of Advanced Breast Cacer 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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature Combining chemotherapy with microwave thermotherapy before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy with or without microwave thermotherapy before surgery in treating women who have locally advanced breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy with or without microwave thermotherapy before surgery in treating women who have locally advanced breast cancer
Detailed Description:
OBJECTIVES
Compare the safety and efficacy of neoadjuvant therapy comprising cytoreductive doxorubicin and cyclophosphamide with or without focused microwave thermotherapy in women with locally advanced breast cancer in an intact breast
Evaluate percentage of patients who achieve at least 85 pathological cell death after treatment with focused microwave thermotherapy
Compare clear pathology tumor margins and reduction of second incision rates in patients treated with these regimens
Compare the amount of surgically removed breast and tumor tissue in patients treated with these regimens
Compare the measurement of the extent of tumor margins in patients treated with these regimens
Compare the reduction of tumor size in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to tumor size T2 vs T3 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cyclophosphamide IV over 15 minutes and doxorubicin IV over 15 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity
During courses 1 and 2 only patients undergo focused microwave thermotherapy on day 1 of chemotherapy or within 36 hours after chemotherapy Patients 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 any unacceptable toxicity a target tumor temperature of 43-47 C is reached and maintained for an equivalent thermal dose of 80-120 minutes
Arm II Patients receive chemotherapy only as in arm I Within 60 days after completion of thermochemotherapy or chemotherapy alone patients in both arms undergo total mastectomy partial mastectomy or other breast-conserving surgery as appropriate At the discretion of the physician beginning after completion of chemotherapy patients in both arms who are estrogen receptor positive may receive oral tamoxifen Within 4 weeks after completion of chemotherapy and surgery eligible patients in both arms also undergo radiotherapy to the breast and lymph nodes
Patients are followed at 30 and 90 days
PROJECTED ACCRUAL A total of 280-312 patients 140-156 per treatment arm will be accrued for this study
Compare the safety and efficacy of neoadjuvant therapy comprising cytoreductive doxorubicin and cyclophosphamide with or without focused microwave thermotherapy in women with locally advanced breast cancer in an intact breast
Evaluate percentage of patients who achieve at least 85 pathological cell death after treatment with focused microwave thermotherapy
Compare clear pathology tumor margins and reduction of second incision rates in patients treated with these regimens
Compare the amount of surgically removed breast and tumor tissue in patients treated with these regimens
Compare the measurement of the extent of tumor margins in patients treated with these regimens
Compare the reduction of tumor size in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to tumor size T2 vs T3 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cyclophosphamide IV over 15 minutes and doxorubicin IV over 15 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity
During courses 1 and 2 only patients undergo focused microwave thermotherapy on day 1 of chemotherapy or within 36 hours after chemotherapy Patients 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 any unacceptable toxicity a target tumor temperature of 43-47 C is reached and maintained for an equivalent thermal dose of 80-120 minutes
Arm II Patients receive chemotherapy only as in arm I Within 60 days after completion of thermochemotherapy or chemotherapy alone patients in both arms undergo total mastectomy partial mastectomy or other breast-conserving surgery as appropriate At the discretion of the physician beginning after completion of chemotherapy patients in both arms who are estrogen receptor positive may receive oral tamoxifen Within 4 weeks after completion of chemotherapy and surgery eligible patients in both arms also undergo radiotherapy to the breast and lymph nodes
Patients are followed at 30 and 90 days
PROJECTED ACCRUAL A total of 280-312 patients 140-156 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-09533 | None | None | None |
| CELSION-10200201 | None | None | None |