Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
06/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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 measures

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

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

http://www.leeds.ac.uk/medicine/nyctru/ctru_contents.htm

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

Results - basic reporting

Publication summary

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11139307

Publication citations

  1. 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.

Additional files

Editorial Notes