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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/1996

Participant type(s)	Patient
Age group	Mixed
Sex	All
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1995
Date of final enrolment	01/01/1996

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	presumed results	01/10/1999	30/10/2019	Yes	No

30/10/2019: Publication reference added.