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 |
| Protocol serial number | N/A |
| Sponsor | Tehran University of Medical Sciences (Iran) |
| Funder | Tehran University of Medical Sciences (Iran) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Response rate |
| Key secondary outcome measure(s) |
Quality of life and survival |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
