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 |
| Secondary identifying numbers | DART |
- 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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Multicentre randomised open label controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/11/1996 |
| Completion date | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Northern and Yorkshire Clinical Trials and Research Unit (UK)
Research organisation
Research organisation
17 Springfield Mount
Leeds
LS2 9NG
United Kingdom
| Website | http://www.leeds.ac.uk/medicine/nyctru/ctru_contents.htm |
|---|
Funders
Funder type
Research organisation
Northern and Yorkshire Clinical Trials and Research Unit (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
