Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LU3002
Study information
Scientific title
Mitomycin, ifosfamide and cisplatin in non-small cell lung cancer (NSCLC): a randomised trial of chemotherapy versus symptomatic treatment only in patients not suitable for radical radiotherapy
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
1. Schedule A: Combination chemotherapy, four, 3 weekly cycles of mitomycin, ifosfamide and cisplatin (MIC). Radiotherapy may be given to patients whose symptoms are not responding to the systemic therapy (in this case chemotherapy should be stopped), and to patients developing symptoms after chemotherapy has stopped. Short and simple radiotherapy schedules of one to ten fractions, not exceeding a total dose of 30 Gy should be given.
2. Schedule B: Palliative care only. Radiotherapy should be used where appropriate. Short and simple schedules of one to ten fractions, not exceeding a total dose of 30 Gy.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
01/01/1996
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 75 years or under
2. Histologically or cytologically proven non-small cell lung cancer, ie adeno-squamous or large cell carcinoma
3. Clinically or radiologically evaluable disease
4. Inoperable, but clinically limited stage disease
5. World Health Organisation (WHO) performance status of 0-2
6. No previous chemotherapy or radiotherapy
7. No cerebral metastases, spinal cord compression or symptomatic superior vena cava obstruction
8. Normal renal function
9. No other previous or concurrent malignancy, except cone biopsied carcinoma in-situ of the cervix and adequately treated basal cell carcinoma of the skin
10. No indication that protocol treatment would exacerbate a serious pre-existing medical condition
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1995
Recruitment end date
01/01/1996
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
1999 presumed results in https://www.ncbi.nlm.nih.gov/pubmed/10506617 (added 30/10/2019)