Comparison of modify Doxotel, Cisplatin, 5fluoracil versus Eloxatin chemotherapy regimens in terms of overall survival and progression free survival in patients with advanced gastric and gastroesophageal junction cancer
(1)Objective ;Comparison of modify Doxotel, Cisplatin, 5fluoracil versus Eloxatin chemotherapy regimens in terms of overall survival and progression (2)Design ;Study double blind, randomized.180 patient select and entire to both groups 80 patients.(3)Setting and conduct ;one group Use Doxotel , Cisplatin, 5Fluoracil and another group Eloxatin.(4)participants including major eligibility criteria; inclusion criteria : female and male; 18 to 65 years;Functional state ; criteria document histological for gastric and gasttoeroesophaseal
Junction adenocarcinoma; patients with unsurgery ; exclusive criteria : peripheral neuropathy; cerebro vascular disease; Myocardial infarction; Pulmonary trombo emboly ; unstable angina ; uncotrol infections; lactation and pregnancy; lower limb arthritis; therapy with phenytoein; (5)main outcome measures; complete remission and partial remission and progress disease and fixed disease calculation and recorded . Than fallow up for side effects of chemotherapy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062134670N1
Registration date:2017-08-07, 1396/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-07, 1396/05/16
Registrant information
Name
Mahin Soleimani
Name of organization / entity
University of Medical Center Jondy Shapor of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3013
Email address
soleimani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jondy Shapor University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of modify Doxotel, Cisplatin, 5fluoracil versus Eloxatin chemotherapy regimens in terms of overall survival and progression free survival in patients with advanced gastric and gastroesophageal junction cancer
Public title
comprarison both type chemothrapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion major eligibility criteria : female and male ;18 until 65 years; functional class; critria for histology of adenocarcinoma gastric and Gastroesophageal junction; not finding for family geoghrafic psyicatric state with effect for ejucation;
exclusion major eligibility criteria : peripheral nouropathy ; Cerebrovascular disease ;Myocardial infarction ; Pulmonary thrombo emboly ; unstable angina ; uncontrol infection ; pregnancy and lactation ; previce medication for adenocarcinoma; lower limd artritic ; thyapy with phenytoin; known malignancy;
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jondy Shapor University of Medical Sciences of ethics committee
Street address
Golestan Street, Ahvaz
City
Ahvaz
Postal code
Approval date
2017-02-25, 1395/12/07
Ethics committee reference number
Ir.ajums.rec.1395.763
Health conditions studied
1
Description of health condition studied
Neoplasm
ICD-10 code
C15-C26
ICD-10 code description
Malignant neoplasms of digestive organ
Primary outcomes
1
Description
Progression free survival
Timepoint
To month
Method of measurement
From start chemotherapy to last follow up or recovery
Secondary outcomes
1
Description
Overall survival
Timepoint
To month
Method of measurement
From start chemotherapy to last follow up or partial recovery
Intervention groups
1
Description
In one group, use chemotherapy to Eloxatin with 130 mg/m2 intravenous for two hours and Epirubicin 50 mg/m2 bolus intravenous and Capecitabine 625 mg/m2 for two days for eight cycles
Category
Treatment - Drugs
2
Description
Two groups use chemotherapy with Docetaxel 40mg/m2 intravenous infusion and Cisplatin 40 mg/m2 intravenous infusion and 5-fluorauacil 400 mg/m2 intravenous infusion for four days for eight cycles
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Jondy Shapor University of Medical Sciences
Street address
Shafa Hospital, Golestan Street,
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research , Jondy Shapor University of Medical Sciences
Full name of responsible person
Dianat mohamad
Street address
Vice chancellor for research, Jondy Shapor University of Medical Sciences, Golestan Street,
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , Jondy Shapor 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
Master of Jondy Shapor University of Medical Sciences
Full name of responsible person
Physician Ahmad Ahmadzadeh
Position
Hematologist
Other areas of specialty/work
Street address
Shafa Hospital, Golestan Street,
City
Ahvaz
Postal code
Phone
+98 61 3374 3013
Fax
Email
Ahmad. Ahmadzadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jondy Shapor University of Medical Sciences
Full name of responsible person
Mahin Soleimani
Position
Resident
Other areas of specialty/work
Street address
Shafa Hospital, Golestan Street,
City
Ahvaz
Postal code
Phone
+98 61 3374 3013
Fax
Email
Mahinsoleimani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jondy Shapor University of Medical Sciences
Full name of responsible person
Mahin Soleimani
Position
Resident
Other areas of specialty/work
Street address
Shafa Hospital, Golestan Street in Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3013
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)