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

ISRCTN	ISRCTN91918581
DOI	https://doi.org/10.1186/ISRCTN91918581
Protocol serial number	DART
Sponsor	Northern and Yorkshire Clinical Trials and Research Unit (UK)
Funder	Northern and Yorkshire Clinical Trials and Research Unit (UK)

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 06/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre randomised open label controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Amifostine, ifosfamide, carboplatin, etoposide
Primary outcome measure(s)	Added 07/08/09: Haemotological toxicity; occurrence of WHO grade 3 or 4 neutropenia or thrombocytopenia during any course of chemotherapy
Key secondary outcome measure(s)	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
Completion date	31/12/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Key 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
Key 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
Date of first enrolment	01/11/1996
Date of final enrolment	31/12/2000

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/01/2001		Yes	No