Lung (small cell) cancer Cancer Malignant neoplasm of bronchus and lung
Conditions
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 e
Sponsors
Northern and Yorkshire Clinical Trials and Research Unit (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added 07/08/09: Haemotological toxicity; occurrence of WHO grade 3 or 4 neutropenia or thrombocytopenia during any course of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed