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 number	NCT00004209
Secondary identifying numbers	95.24

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Mitomycin, vinblastine and platinum (cisplatin)
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1993
Completion date	30/11/1998

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2001	16/04/2019	Yes	No

16/04/2019: Publication reference and total final enrolment added.