A randomised study of Mitomycin, Vinblastine and Platinum (cisplatin) (MVP) three versus six cycles in advanced Non-Small Cell Lung Cancer (NSCLC)
| ISRCTN | ISRCTN57675565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57675565 |
| ClinicalTrials.gov (NCT) | NCT00004209 |
| Protocol serial number | 95.24 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 16/04/2019
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised study of Mitomycin, Vinblastine and Platinum (cisplatin) (MVP) three versus six cycles in advanced Non-Small Cell Lung Cancer (NSCLC) |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lung (non-small cell) cancer |
| Intervention | Cisplatin 50 mg/m2 Mitomycin-C 8 mg/m^2 intravenous (iv) day one Vinblastine 6 mg/m^2 iv day one |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mitomycin, vinblastine and platinum (cisplatin) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/11/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Total final enrolment | 308 |
| Key inclusion criteria | 1. Histological evidence of NSCLC 2. Stage IIIb or IV disease not eligible for surgery or radical radiotherapy 3. Performance status zero, one or two 4. Ability to give signed, informed consent 5. 51Cr Ethylene Diamine Tetraacetic Acid (EDTA) more than 60 ml/min, creatinine clearance more than 60 ml/min, Haemoglobin (Hb) more than 10 g/dl, White Cell Count (WCC) more than 3 x 10^9/l, platelets 100 x 10^12/l, Liver Function Tests (LFTs) not more than two times normal unless due to metastatic disease |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1993 |
| Date of final enrolment | 30/11/1998 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2001 | 16/04/2019 | Yes | No |
Editorial Notes
16/04/2019: Publication reference and total final enrolment added.
