| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN39679215 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | Study 10 |
| Public title | A Phase III Randomised comparison of Gemcitabine/Carboplatin with Cisplatin/Etoposide in Small Cell Lung Cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Lung (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 small cell anaplastic carcinoma of the lung
2. Extensive stage disease or limited stage but locally advanced or limited stage with poor prognostic factors
3. Measurable or evaluable disease
4. Adequate renal function for chemotherapy
5. Age 18 years or above
6. Adequate contraception for women of child bearing potential
7. Written informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 31/10/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | GC Arm: 3-weekly regimen (6 cycles) Gemcitabine 1200 mg/m(2) IV (Day 1 and 8) Carboplatin (AUC 5) Dose in mg calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day1)
PE Arm: 3-weekly regime (6 cycles): Cisplatin 60 mg/m2 IV Day 1 Etoposide 120 mg/m2 IV (Day 1) and 100 mg bd po (days 2 and 3) |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | NCRI CSG and London Lung Cancer Group |
| Sponsor name | NCRI CSG and 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 | ISRCTN39679215 |
| Date last extracted from ISRCTN register | 17/04/2008 |
