Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DART
Study information
Scientific title
Acronym
Study hypothesis
Added 07/08/09:
The aim of this trial is to determine whether the administration of amifostine before each cycle of modified ICE can attenuate the toxicity of the chemotherapy.
As of 07/08/09 this trial has been extensively updated. All updates can be found under the relevant field with the above update date. Please not that the start and end dates of this trial were changed from 01/08/2002 and 01/08/2003 respectively as these dates were automatically generated at the time of registration.
Ethics approval
Not provided at time of registration
Study design
Multicentre randomised open label controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Lung (small cell) cancer
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Amifostine, ifosfamide, carboplatin, etoposide
Primary outcome measure
Added 07/08/09:
Haemotological toxicity; occurrence of WHO grade 3 or 4 neutropenia or thrombocytopenia during any course of chemotherapy
Secondary outcome measures
Added 07/08/09:
1. Response rate
2. Non-haemological toxicity
3. Survival
4. Hospitalisation
5. Antibiotic usage
6. Anti-emetic usage
7. Transfusions
8. Renal impairment
9. Health Economonic (HE) assessment
Cost effectiveness
Overall trial start date
01/11/1996
Overall trial end date
31/12/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with histologically or cytologically proven non-small cell lung cancer
2. Patients with either:
2.1. Limited disease with World Health Organisation (WHO) performance status zero to one
2.2. Limited disease performance status two, normal sodium and alkaline phosphatase
2.3. 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. Adequate renal and hepatic function
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Prior cytotoxic therapy or radiotherapy
2. History of other malignant disease (except basal cell carcinoma or squamous cell cancer of the skin or in situ carcinoma of the cervix)
3. Symptomatic heart disease or other active infection or illness which would preclude chemotherapy
Recruitment start date
01/11/1996
Recruitment end date
31/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Northern and Yorkshire Clinical Trials and Research Unit (UK)
Sponsor details
17 Springfield Mount
Leeds
LS2 9NG
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Northern and Yorkshire Clinical Trials and Research Unit (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11139307
Publication citations
-
Results
Johnson PW, Muers MF, Peake MD, Poulter KM, Gurney EM, Napp VV, Hepburn PM, Brown JM, A randomized trial of amifostine as a cytoprotective agent in patients receiving chemotherapy for small cell lung cancer., Br. J. Cancer, 2001, 84, 1, 19-24, doi: 10.1054/bjoc.2000.1539.