Randomised phase II study of sequentially high dose Methotrexate and Fluorouracil combined with Epirubicin (FEMTX) versus FEMTX plus Cisplatin (FEMTX-P) in advanced gastric cancer
| ISRCTN | ISRCTN69546136 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69546136 |
| Secondary identifying numbers | ICCG/8/91 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 30/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised phase II study of sequentially high dose Methotrexate and Fluorouracil combined with Epirubicin (FEMTX) versus FEMTX plus Cisplatin (FEMTX-P) in advanced gastric cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oesophagus, Stomach Cancer |
| Intervention | Patients are randomised to one of four treatment arms: 1. Arm A: Chemotherapy with FEMTX 2. Arm B: Chemotherapy with FEMTX plus Granulocyte Colony Stimulating Factor (G-CSF) 3. Arm C: Chemotherapy with FEMTX-P 4. Arm D: Chemotherapy with FEMTX-P plus G-CSF Centres may choose to randomise to Arms A and Arm C only. FEMTX: Chemotherapy with 5-flourouracil, high-dose methotrexate and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles. FEMTX-P: Chemotherapy with 5-flourouracil, high-dose methotrexate, cisplatinum and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methotrexate, fluorouracil, epirubicin and cisplatin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1996 |
| Completion date | 01/01/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Aged less than 70 years 2. Histologically confirmed locally advanced and/or metastatic gastric cancer 3. Measurable or evaluable disease 4. Karnofsky status 80-100 5. Adequate renal, hepatic and bone marrow function |
| Key exclusion criteria | 1. Previous chemotherapy or radiotherapy 2. Pleural or peritoneal effusions which cannot be adequately drained 3. Central Nervous System (CNS) metastases 4. History of previous or concomitant malignancy except squamous or basal cell carcinoma of the skin which has been effectively treated and carcinoma in situ of the cervix which has been treated operatively only 5. Other medical contraindications to treatment protocols |
| Date of first enrolment | 01/01/1996 |
| Date of final enrolment | 01/01/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Pharmacia Ltd & Upjohn (UK)
Industry
Industry
Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
| Phone | +44 (0)1908 661101 |
|---|---|
| info@adreco.co.uk | |
| Website | http://www.pharmacia.com |
"ROR" |
https://ror.org/04x4v8p40 |
Funders
Funder type
Industry
Pharmacia and Upjohn Ltd (UK)
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 |
Editorial Notes
30/10/2019: No publications found, all search options exhausted, study status unverified.
30/11/2015: No publications found in PubMed.
