Condition category
Cancer
Date applied
03/07/2006
Date assigned
28/07/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes