Overview

Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Lung Cancer Working Party
Treatments:
Cisplatin
Docetaxel
Gemcitabine
Ifosfamide
Isophosphamide mustard
Criteria
Inclusion Criteria:

- Histological or cytological diagnosis of non-small cell lung cancer

- Advanced (unresectable or functionally inoperable) stage III or stage IV disease

- Availability for participating in the detailed follow-up of the protocol

- Presence of an evaluable or measurable lesion

- Informed consent

Exclusion Criteria:

- Prior treatment with chemotherapy

- Operable patient with resectable tumour

- Performance status < 60 on the Karnofsky scale

- A history of prior malignant tumour, except non-melanoma skin cancer or in situ
carcinoma of the cervix and cured malignant tumour (more than 5-year disease free
interval)

- Polynuclear cells < 2,000/mm³

- Platelet cells < 100,000/mm³

- Serum bilirubin >1.5 mg/100 ml

- Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min

- Perception hypoacousia

- Peripheral neuropathy

- Recent myocardial infarction (less than 3 months prior to date of diagnosis)

- Congestive cardiac failure requiring medical therapy or uncontrolled cardiac
arrhythmia

- Uncontrolled infectious disease

- Serious medical or psychological factors which may prevent adherence to the treatment
schedule