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
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