| Source of record | UK Trials |
| ISRCTN | ISRCTN92669260 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | TR7SCLC |
| Public title | Randomised trial of two schedules of chemotherapy of the same dose/time intensity in untreated small cell lung cancer (SCLC) of poor prognosis |
| 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 carcinoma of the lung
2. Aged 75 or under
3. Extensive disease and poor prognosis, ie Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3 and/or alkaline phosphatase >1.5 upper limit of normal range
4. Adequate renal function
5. No previous malignancy, except non melanomatous skin cancer in the preceding 3 years
6. No previous chemotherapy or radiotherapy, except for emergency radiotherapy for superior vena cava obstruction
7. No medical contraindications to treatment |
| 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. Standard Regimen:
Multi-drug chemotherapy, cyclophosphamide, adriamycin and vincristine alternating every 21 days with etoposide and cisplatin. A total of six courses, three with each drug combination.
2. Low Dose/High Frequency Regimen:
Multi-drug chemotherapy, etoposide and cisplatin alternating every 10/11 days with cyclophosphamide, adriamycin and vincristine. A total of twelve courses, six with each drug combination. This schedule uses the same drugs as in the standard regimen but at half the dose and twice the frequency with the same intended overall dose intensity. |
| 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 | ISRCTN92669260 |
| Date last extracted from ISRCTN register | 17/04/2008 |
