Determination of percentage of pathologic complete respone by adding Oxaliplatin to neoadjuvent chemotherapy regimen in locally advanced breast cancer; Determination of drug toxicity(including hematologic,hepatic, renal toxicity) by adding Oxaliplatin to neoadjuvent chemotherapy regimen in locally advanced breast cancer
Design
Non randomized and non controlled phase 2 single arm clinical trial
Settings and conduct
locally advanced breast cancer patient who will be treated in radiation oncology department of Shiraz Namazi hospital will be treated by 4 courses doxorubicin and cyclophsphamide then 4 course docetaxel and oxaliplatin every 3 weeks and evaluated in terms of pathologic complete response and drug toxicity.
Participants/Inclusion and exclusion criteria
Female adults (20-70 years old) who are histopathologically confirmed locally advanced breast cancer (clinical stage T3, T4, and/or N2, N3) with Eastern Cooperative Oncology Group Performance status of 0 or 1 and acceptable complete blood count, liver function test, renal function test; The patient should not have active infection, pregnancy, other primary malignancy, any documented distant metastasis, uncontrolled systemic diseases. (including severe cardiovascular, kidney and liver disease) and refusal to participate in this trial.
Intervention groups
Adding oxaliplatin to neoadjuvent chemotherapy regimen
Main outcome variables
pathologic respone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042104N1
Registration date:2019-03-28, 1398/01/08
Registration timing:prospective
Last update:2019-03-28, 1398/01/08
Update count:0
Registration date
2019-03-28, 1398/01/08
Registrant information
Name
Mehdi ُShariat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3636 3183
Email address
mshariat@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of efficacy and safety of adding Oxaliplatin to neoadjuvant chemotherapy in locally advanced breast cancer patients
Public title
Determination of efficacy and safety of Oxaliplatin in locally advanced breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Histologically confirmed locally advanced breast cancer
Clinical stage T3, T4, and/or N2, N3
Patients with Eastern Cooperative Oncology Group performance status of 0 or 1
Absolute neutrophil count > 1500/ mm3
Hemoglobin > 8.0 g/dL
Platelet count > 100,000/mm3
Creatinine < 2.5 times the upper limit of normal (ULN)
Serum transaminases < 2.5 times ULN
Serum alkaline phosphatase < 4 times ULN
Total bilirubin < 2.5 times ULN
Exclusion criteria:
Active infection
Pregnancy
Other primary malignancy
Any documented distant metastasis
Uncontrolled systemic diseases (including severe cardiovascular, kidney and liver disease)
Patients refusal to participate in the trial
Age
From 20 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor for Research, Shiraz faculty of Medicine, Zand Ave, Shiaz faculty of Medicine, Zand Ave
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2018-01-16, 1396/10/26
Ethics committee reference number
IR.SUMS.MED.REC.1396.80
Health conditions studied
1
Description of health condition studied
locally advanced breast cancer
ICD-10 code
C50.919
ICD-10 code description
Malignant neoplasm of unspecified site of unspecified female breast
Primary outcomes
1
Description
Percentage of pathologic complete response
Timepoint
After surgery
Method of measurement
Histopathologic evaluation
Secondary outcomes
1
Description
drug toxicity including hematologic,hepatic renal toxicity
Timepoint
every 3 weeks during patients visit
Method of measurement
blood test for evaluation of hematologic; renal; hepatic factors
Intervention groups
1
Description
Intervention group: adding oxaliplatin with dose 130 mg per m2 for 4 cycles every 3 weeks to chemotherapy regimen
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Mehdi Shariat
Street address
Namazi Hospital; Namzi Square; Shiraz
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
radiodept4@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice-Chancellor for Research; Shiraz University of Medical Sciences; Zand Blvd; Shiraz
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Fax
+98 71 3230 7594
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?