A Multicentre Randomised Feasibility Study of Adjuvant Chemotherapy (CT) following Radical Primary Treatment for Transitional Cell Carcinoma (TCC) of the Bladder
| ISRCTN | ISRCTN16638426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16638426 |
| Secondary identifying numbers | EMI Study |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 30/05/2012
- 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 - -
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 | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer of bladder (advanced) |
| Intervention | Total Cystectomy or Radical RT +/- CT CT: Methotrexate 30 mg/m^2 (days 1, 15, 22) Vinblastine 3 mg/m^2 (days 2, 15, 22) Adriamycin 30 mg/m2 (day 2) Cisplatin 70 mg/m2 (day 2) every 28 days, maximum of three cycles |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methotrexate, vinblastine, adriamycin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2000 |
| Completion date | 15/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Histologically confirmed invasive TCC of the bladder 2. Stage T2, T3a, T3b, T4a, N0 or T(any), N1/N2 3. Patient has undergone a complete resection at cystectomy or has received radical radiotherapy with curative intent 4. Fit enough to undergo combination chemotherapy 5. Creatinine clearance >60ml/min within 10 weeks of primary treatment 6. Haematological counts within 4 weeks before randomisation: White Blood Count (WBC) >3x10^9/l Platelets >100 x10^9/l Haemoglobin >10g/dl 7. Patient must be able to commence CT within 12 weeks of completion of primary treatment 8. Written informed consent |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 15/02/2002 |
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
Northern Research and Development (UK)
Research organisation
Research organisation
-
Durham
-
United Kingdom
Funders
Funder type
Research organisation
Northern Research and Development (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Yes | No |
