Mitomycin, ifosfamide and cisplatin in non-small cell lung cancer (NSCLC): A randomised trial of chemotherapy plus radiotherapy versus radiotherapy alone

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
Study type	Participant information sheet
Scientific title
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). Followed by radiotherapy as decided by the radiotherapist. The total minimum dose should not be less than 40 Gy in fifteen fractions and the field size adequate to encompass the known extent of the tumour. 2. Schedule B: Radiotherapy as decided by the radiotherapist. The total minimum dose should not be less than 40 Gy in fifteen fractions and the field size adequate to encompass the known extent of the tumour.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Mitomycin, ifosfamide and cisplatin
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	Adult
Sex
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. WHO performance status of 0-2 6. No previous chemotherapy or radiotherapy 7. No metastatic disease, except ipsilateral stem cell factor (SCF) lymphadenopathy 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 pleural effusion or symptomatic superior vena cava obstruction 11. No pre-existing severe impairment of lung function likely to prejudice the safe administration of the proposed radiotherapy 12. 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	01/01/1990
Date of final enrolment	01/01/1996

UKCCCR Register Co-ordinator

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	results	01/10/1999		Yes	No
Other publications	interim analysis	01/04/1995		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes