| Source of record | UK Trials |
| ISRCTN | ISRCTN38657696 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LU3002 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lung (non-small cell) cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1995 |
| Anticipated end date | 01/01/1996 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN38657696 |
| Date last extracted from ISRCTN register | 17/04/2008 |
