Compare the complementary effect of radiofrequency ablation technique besides chemotherapy in patients with metastatic liver tumors from breast and control group under chemotherapy
The purpose of this study is to evaluate the effect of radio frequency ablation (RFA) technique on treatment of liver metastatic tumors from breast cancer. In this randomised clinical trial, patients with liver metastases from breast cancer who refer to interventional radiology centre will be enrolled. Patients should have less than 5 lesions which are smaller than 5 cm. They will be divided into two groups. Patients in the case group take chemotherapy and RFA during their treatment procedure, but in the control group only chemotherapy will be taken. Patients in both groups will be matched based on age, sex, race, tumour type, number of tumours, duration of disease and type of previous treatment (surgery/chemotherapy). CT scan with and without contrast will be done 3 weeks after general chemotherapy in the control group and RFA and chemotherapy in the case group. To assess the treatment response, CT exam will be done for the following 3 and 6 months. The size, frequency, contrast agent absorption and the status of residual liver tumour will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010931062N2
Registration date:2017-04-24, 1396/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-24, 1396/02/04
Registrant information
Name
zahra mardanshahi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 5348
Email address
mardanshahi56@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research department, Mazandaran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the complementary effect of radiofrequency ablation technique besides chemotherapy in patients with metastatic liver tumors from breast and control group under chemotherapy
Public title
Compare the complementary effect of radiofrequency ablation technique besides chemotherapy in patients with metastatic liver tumors from breast and control group under chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: liver metastatic lesion from breast tissue verified by pathology; liver metastatic lesion far from intrahepatic bile ducts; liver metastatic lesion far from great veins more than 3 cm
Exclusion criteria: Acute febrile infection; Cr>2; Ascites; hepatic encephalopathy; INR>1.5; Bill>3; verified extrahepatic metastases; surgery candidates
Age
From 35 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Mazandaran University of Medical Sciences
Street address
Research department of Mazandaran University of Medical Sciences, Moallem square
City
Sari
Postal code
Approval date
2016-04-21, 1395/02/02
Ethics committee reference number
IR.MAZUMS.REC.95.2165
Health conditions studied
1
Description of health condition studied
liver metastases from breast cancer
ICD-10 code
C79.8
ICD-10 code description
Secondary malignant neoplasm of other specified sites
Primary outcomes
1
Description
ٰThe status of residual liver tumour
Timepoint
3 weeks after treatment, 3 months and 6 months after treatment
Method of measurement
Evaluate CT scan images with and without contrast
2
Description
Liver tomur size
Timepoint
3 weeks after treatment, 3 months and 6 months after treatment
Method of measurement
Evaluate CT scan images with and without contrast
3
Description
Frequency of liver tumors
Timepoint
3 weeks after treatment, 3 months and 6 months after treatment
Method of measurement
Evaluate CT scan images with and without contrast
4
Description
Contrast agent absorption by liver tumor
Timepoint
3 weeks after treatment, 3 months and 6 months after treatment
Method of measurement
Evaluate CT scan images with and without contrast
Secondary outcomes
empty
Intervention groups
1
Description
Case group will receive both RFA and chemotherapy
Chemotherapy regimen
FEC: Cycle length: 21 days - Duration of therapy: 6 to 8 cycles.
Fluorouracil 500 mg/m2 IV - Once a day
Epirubicin 100 mg/ m2 IV - Once a day
Cyclophosphamide 500 mg/ m2 IV - Once a day
--------------------
RFA is done by Active Tip electrode (Mygene-Korea) and with 1.5, 2 and 3 centimeter ablation depth
Category
Treatment - Other
2
Description
Control group will receive just chemotherapy
Chemotherapy regimen
FEC: Cycle length: 21 days - Duration of therapy: 6 to 8 cycles.
Fluorouracil 500 mg/m2 IV - Once a day
Epirubicin 100 mg/ m2 IV - Once a day
Cyclophosphamide 500 mg/ m2 IV - Once a day
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Partomazand Imaging Center
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research department, Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Bagher Montazeri
Street address
Research department of Mazandaran University of Medical Sciences, Moallem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research department, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Mardanshahi
Position
Assistant professor/ Radiology
Other areas of specialty/work
Street address
AmiMazandarani Blvd, Imam khomeini hospital
City
Sari
Postal code
Phone
+98 911 156 5082
Fax
Email
zmardanshahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran university of medical sciences
Full name of responsible person
Zahra Mardanshahi
Position
Assistant professor/ Radiology
Other areas of specialty/work
Street address
Amir mazandarani St, Imam khoemini hospital
City
Sari
Postal code
Phone
+98 911 156 5082
Fax
Email
zmardanshahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Tayebi
Position
Master of Medical Imaging
Other areas of specialty/work
Street address
Amir mazandarani St, Imam khoemini hospital
City
Sari
Postal code
Phone
+98 938 112 6101
Fax
Email
mary.tayebi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)