Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

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

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 measures

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

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

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

http://www.cancer.org.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes