Contact information
Type
Scientific
Primary contact
Dr Sanambar Sadighi
ORCID ID
Contact details
Cancer Institute
Emam Hospital
Tehran
-
Iran
ssadighi@doctor.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Quality of life does not differ in advanced gastric cancer patients after receiving either docetaxel, cisplatin and 5-fluorouracil (5-FU) (TCF regiment) versus epirubicin, cisplatin and 5-FU (ECF-regimen).
Ethics approval
Ethics committee of the Tehran University of Medical Sciences November 2001
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Gastric cancer
Intervention
Three to six cycles of either ECF (epirubicin 60 mg/m^2, cisplatin 60 mg/m^2 and 5-FU 750 mg/m^2/day as a five-day continuous infusion) or TCF regimen (docetaxel 60 mg/m^2, cisplatin 60 mg/m^2 and 5FU in the same dose and schedule of ECF) every three weeks.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Response rate
Secondary outcome measures
Quality of life and survival
Overall trial start date
01/01/2002
Overall trial end date
01/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with histologically confirmed advanced gastric cancer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
86
Participant exclusion criteria
Patients with local or local- regional gastric cancer
Recruitment start date
01/01/2002
Recruitment end date
01/01/2005
Locations
Countries of recruitment
Iran
Trial participating centre
Cancer Institute
Tehran
-
Iran
Sponsor information
Organisation
Tehran University of Medical Sciences (Iran)
Sponsor details
Enghelab Avenue
Tehran
-
Iran
info@sina.tums.ac.ir
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Tehran University of Medical Sciences (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17147808
Publication citations
-
Results
Sadighi S, Mohagheghi MA, Montazeri A, Sadighi Z, Quality of life in patients with advanced gastric cancer: a randomized trial comparing docetaxel, cisplatin, 5-FU (TCF) with epirubicin, cisplatin, 5-FU (ECF)., BMC Cancer, 2006, 6, 274, doi: 10.1186/1471-2407-6-274.