Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00004209
Protocol/serial number
95.24
Study information
Scientific title
A randomised study of Mitomycin, Vinblastine and Platinum (cisplatin) (MVP) three versus six cycles in advanced Non-Small Cell Lung Cancer (NSCLC)
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Mitomycin, vinblastine and platinum (cisplatin)
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1993
Overall trial end date
30/11/1998
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Total final enrolment
308
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1993
Recruitment end date
30/11/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2001 results in: https://www.ncbi.nlm.nih.gov/pubmed/11230476 (added 16/04/2019)