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ISRCTN
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ISRCTN56319613
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ClinicalTrials.gov identifier
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Public title
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Mitomycin, ifosfamide and cisplatin in non-small cell lung cancer (NSCLC): A randomised trial of chemotherapy plus radiotherapy versus radiotherapy alone
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Scientific title
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Acronym
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N/A
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Serial number at source
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LU3001
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lung (non-small cell) cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1990
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Anticipated end date
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01/01/1996
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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23/05/2008
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Date ISRCTN assigned
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01/07/2001
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