| Source of record | UK Trials |
| ISRCTN | ISRCTN73797340 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | TR9SCLC |
| Public title | A randomised study of oral versus intravenous chemotherapy in poor prognosis small cell lung cancer (SCLC) |
| 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 SCLC
2. Patients with extensive disease and poor prognosis, ie Eastern Cooperative Oncology Group (ECOG) performance 2 or 3 or alkaline phosphatase >1.5 upper limit normal range
3. Patients 75 years and over, whatever stage of disease, deemed fit for randomisation
4. No previous malignancy, except non melanomatous skin cancer in the preceding 3 years
5. No medical contraindications to treatment
6. Adequate renal function |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Regimen A: Chemotherapy, oral etoposide repeated every 3 weeks for six courses.
2. Regimen B: Multi-drug chemotherapy, CAV (cyclophosphamide, adriamycin, vincristine) alternating every 3 weeks with PE (etoposide, cisplatin). A total of six courses, three with each drug combination. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Not available |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| 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 | ISRCTN73797340 |
| Date last extracted from ISRCTN register | 17/04/2008 |
