Quality of life in patients with advanced gastric cancer: a randomized trial comparing docetaxel, cisplatin and 5-fluorouracil against epirubicin, cisplatin and 5-fluorouracil
| ISRCTN | ISRCTN83369741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83369741 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/07/2006
- Registration date
- 28/07/2006
- Last edited
- 25/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sanambar Sadighi
Scientific
Scientific
Cancer Institute
Emam Hospital
Tehran
-
Iran
| ssadighi@doctor.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Ethics committee of the Tehran University of Medical Sciences November 2001 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Response rate |
| Secondary outcome measures | Quality of life and survival |
| Overall study start date | 01/01/2002 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 86 |
| Key inclusion criteria | Patients with histologically confirmed advanced gastric cancer |
| Key exclusion criteria | Patients with local or local- regional gastric cancer |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- Iran
Study participating centre
Cancer Institute
Tehran
-
Iran
-
Iran
Sponsor information
Tehran University of Medical Sciences (Iran)
University/education
University/education
Enghelab Avenue
Tehran
-
Iran
| info@sina.tums.ac.ir | |
"ROR" |
https://ror.org/01c4pz451 |
Funders
Funder type
University/education
Tehran University of Medical Sciences (Iran)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/12/2006 | Yes | No |
