| Source of record | UK Trials |
| ISRCTN | ISRCTN91918581 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | DART |
| Public title | A randomised study to assess whether the administration of amifostine with modified Ifosfamide, Carboplatin and Etoposide (ICE) chemotherapy attenuates the toxicity treatment in patients with good prognosis small cell lung cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lung (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. Patients with histologically or cytologically proven non-small cell lung cancer
2. Patients with either:
a. Limited disease with World Health Organisation (WHO) performance status zero to one
b. Limited disease performance status two, normal sodium and alkaline phosphatase
c. Extensive disease, performance status zero to one, normal sodium alkaline phosphatase, and no documented Central Nervous System (CNS) disease
3. Aged under 75 years
4. Systolic blood pressure of at least 90 mmHg
5. No prior cytotoxic therapy or radiotherapy
6. No history of other malignant disease (except basal cell carcinoma or squamous cell cancer of the skin or in situ carcinoma of the cervix)
7. Adequate renal and hepatic function
8. No symptomatic heart disease or other active infection or illness which would preclude chemotherapy |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/08/2002 |
| Anticipated end date | 01/08/2003 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to one of two treatment groups:
1. Group A: Amifostine infusion followed immediately by modified chemotherapy with Ifosfamide, Carboplatin and Etoposide (ICE). Cycle repeated every 21 days for six cycles
2. Group B: Modified chemotherapy with ICE. Cycle repeated every 21 days for six cycles |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Northern and Yorkshire Clinical Trials and Research Unit (UK) |
| Sponsor name | Northern and Yorkshire Clinical Trials and Research Unit (UK) |
| Sponsor details | 17 Springfield Mount
Leeds
United Kingdom
LS2 9NG |
| Sponsor website | http://www.leeds.ac.uk/medicine/nyctru/ctru_contents.htm |
| 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 | ISRCTN91918581 |
| Date last extracted from ISRCTN register | 17/04/2008 |
