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

Phase 3

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Cisplatin, Ifosfamide, Gemcitabine; Drug: Ifosfamide, Gemcitabine; Drug: Cisplatin, docetaxel

• Registration Number: NCT00622349
• Lead Sponsor: European Lung Cancer Working Party

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-25
• Primary Completion: 2009-03
• Study Completion: 2009-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-29
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 707

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Cisplatin, Ifosfamide, Gemcitabine	-
B	Ifosfamide, Gemcitabine	-
C	Cisplatin, docetaxel	-

Primary Outcome Measures

Name	Time	Method
Survival	Survival will be dated from the first day of registration until death or last follow up

Secondary Outcome Measures

Name	Time	Method
Response rate	Every 3 courses of chemotherapy
Toxicity	After each course of chemotherapy
Activity of second-line chemotherapy	Every 3 courses of chemotherapy

Trial Locations

Locations (4)

Hellenic Cancer Institute - St Savas Oncology Hospital; 🇬🇷 Athens, Greece

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Pneumology department of CHU Lille; 🇫🇷 Lille, France

Medical Oncology Hospital de Sagunto; 🇪🇸 Valencia, Spain