| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN52253218 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | Study 11 |
| Public title | A Phase III randomised comparison of Gemcitabine/Carboplatin with Mitomycin, Ifosfamide and Cisplatin in non-small cell lung cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lung (non-small cell) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histologically or cytologically proven non-small cell carcinoma of the lung
2. Stage IIIb or IV disease
3. Measurable or evaluable disease
4. Adequate renal function (Ethylene diamine tetraacetic acid [EDTA] Clearance >60 ml/min)
5. Age 18 or over
6. Adequate contraception in females of child-bearing potential
7. Written informed consent
8. No prior radiotherapy or chemotherapy
9. Not less than 8 weeks life expectancy
10. No history of prior malignancy (except non-melanomatous skin tumour or has been without evidence of disease for 3 years or more)
11. White cell count >3000/ml Platelet count >100,000/ml Haemaglobin >10.0 g.dL
12. No symptomatic brain metastases |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 31/08/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | GC Arm: 3-weekly regimen. Gemcitabine 1200 mg/m2 IV (Day 1 and 8) Carboplatin (AUC 5). Dose calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day 1)
MIC 3-Weekly regimen: Mitomycin 6 mg/m2 IV (Day 1) Ifosfamide 3 g/m2 IV (Day 1) Cisplatin 50 mg/m2 IV (Day 1) |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | London Lung Cancer Group |
| Sponsor name | London Lung Cancer Group |
| Sponsor details |
London
United Kingdom
|
| 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 | ISRCTN52253218 |
| Date last extracted from ISRCTN register | 17/04/2008 |
