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