Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
10/10/2012
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

Dr - -

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

Protocol/serial number

L14

Study information

Scientific title

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Lung (non-small cell) cancer

Intervention

All patients receive chemotherapy with MVP (mitomycin-C, vinblastine and moderate dose cisplatin) repeated every 21 days for three courses. Mitomycin-C in given with the first and second course only.
Patients responding to treatment or with stable disease are randomised to either:
1. Arm A: Three further cycles of MVP chemotherapy. Mitomycin-C is given with the first and third course only.
2. Arm B: Best supportive care.

Intervention type

Drug

Phase

Not Specified

Drug names

Mitomycin-C, Vinblastine and Moderate Dose Cisplatin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histological evidence of non-small cell lung cancer
2. Stage IIIb or IV disease not eligible for neoadjuvant chemotherapy and/or radical radiotherapy
3. Performance status <2 (Zubrod-Eastern Cooperative Oncology Group [ECOG]-World Health Organisation [WHO] scale)
4. Adequate renal, bone marrow, and lung function tests unless due to metastatic disease
5. Patients must already have achieved symptom relief after three cycles of MVP chemotherapy
6. No uncontrolled infection
7. No previous conventional chemotherapy prior to MVP. One prior phase I/II new drug is allowed
8. No medical contraindications to treatment protocols

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

01/01/2000

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

The Royal Marsden NHS Foundation Trust (UK)

Sponsor details

Downs Road
Sutton
SM2 5PT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Marsden Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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