the goal of this open-label study is comparison between the Rosastim,the domestic product, and Neopogen,the brand type, in order to show the same efficiency in gastric cancers through two parallel group. This study aid to reduce the costs and help patients to ease and availability of drugs, and plays the vital role in improve the local economy as well. inclusion criteria are patients with gasteric cancer from both sex and exclusion criteria includes ill-informed patient consent for participation and hypersensivity or other illness.Patients in each group treat with modified Ajani regimen.this diet includes Docetaxel,Cisplatin and Flourouracil.The mentioned regimen repeat every three weeks and duration of treatment is six cycles that takes about 4-5 months. The capacity of sample is 60 patients and duration of study had predicted about 18 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061118061N1
Registration date:2014-10-20, 1393/07/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-20, 1393/07/28
Registrant information
Name
Mehdi Mohammadzadeh
Name of organization / entity
Behin Tamin Rosamed Co.
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 1982
Email address
info@iapme.ir
Recruitment status
Recruitment complete
Funding source
Behin Tamin Rosamed Co.
Expected recruitment start date
2013-04-20, 1392/01/31
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A therapeutic and side effects comparison between Rosastim and Brand type (Neupogen) in gastric cancer
Public title
A therapeutic and side effects comparison between domestic type and the similar brand in gastric cancer.
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria: 1.Patients with gastric cancers, age 18-65, both sex 2.Biopsy and pathology results 3.Filling the consent form through patients or guardian 4.Possible cooperation of patients till the study completed.
exclusion criteria: 1.Ill-informed patient consent for participation in the study 2.Initial CBC disruption, so that lead to the wrong result in lab tests 3.Hypersensitivity to one type of Granolocyte Colony Stimulating Factor 4.History of treated malignancy or co-current malignancy 5.patient may require radiation during treatment 6.recurrent gastric cancer or refractory one that have previously been treated 7.Inappropriate performance status for start or continue treatment 8.Mental illness or depression such that the compliance reduce.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
ُshahid Beheshti University of Medical Science
Street address
Taleghani Hospital, Velenjak Ave.
City
Tehran
Postal code
1985717443
Approval date
2013-04-28, 1392/02/08
Ethics committee reference number
400/532
Health conditions studied
1
Description of health condition studied
Gasteric cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
White Blood Cell / Platlet / Hemoglubin measurement
Timepoint
triweekly
Method of measurement
Blood sample and Cell Blood Count measurement
Secondary outcomes
1
Description
CRAMP OF LOWER LIMB , Balance cerebellar
Timepoint
triweekly
Method of measurement
Check up
Intervention groups
1
Description
Neupogen prefilled syringe 300 microgram per 0.5 mL is as a control group, duration of treatment for each patient is about six months. blood sampling is done consecutive days, then one day is rest, after that sampling is done every other day. this process repeats triweekly till eight times.
Category
Treatment - Drugs
2
Description
Rosastim 300ug/0.5mL is a subcutaneous prefilled syringe. duration of treatment for each patient is about six months. blood sampling is done consecutive days, then one day is rest, after that sampling is done every other day. this process repeats triweekly till eight times.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospitl
Full name of responsible person
Dr Babak Salimi
Street address
Velenjak Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Behin Tamin Rosamed Co.
Full name of responsible person
Dr Mehdi Mohammadzadeh
Street address
No.82, Nasseri St,Valie asr St,Tehran, Iran
City
Tehran
Grant name
خصوصی
Grant code / Reference number
ندارد
Is the source of funding the same sponsor organization/entity?