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

European Lung Cancer Working Party

Status and phase

Completed

Phase 3

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Ifosfamide, Gemcitabine

Drug: Cisplatin, Ifosfamide, Gemcitabine

Drug: Cisplatin, docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00622349

ELCWP-01041

Details and patient eligibility

About

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

Enrollment

707 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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