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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622349
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Cisplatin, Ifosfamide, Gemcitabine Drug: Ifosfamide, Gemcitabine Drug: Cisplatin, docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 707 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer
Study Start Date : February 2004
Actual Primary Completion Date : March 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Ifosfamide

Arm Intervention/treatment
Experimental: A Drug: Cisplatin, Ifosfamide, Gemcitabine
Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks

Active Comparator: B Drug: Ifosfamide, Gemcitabine
Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks

Experimental: C Drug: Cisplatin, docetaxel
Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks

Primary Outcome Measures :
  1. Survival [ Time Frame: Survival will be dated from the first day of registration until death or last follow up ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: Every 3 courses of chemotherapy ]
  2. Toxicity [ Time Frame: After each course of chemotherapy ]
  3. Activity of second-line chemotherapy [ Time Frame: Every 3 courses of chemotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622349

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Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
Pneumology department of CHU Lille
Lille, France
Hellenic Cancer Institute - St Savas Oncology Hospital
Athens, Greece
Medical Oncology Hospital de Sagunto
Valencia, Spain
Sponsors and Collaborators
European Lung Cancer Working Party
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Study Chair: Jean-Paul Sculier, MD, PhD European Lung Cancer Working Party

Additional Information:
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Responsible Party: European Lung Cancer Working Party Identifier: NCT00622349     History of Changes
Other Study ID Numbers: ELCWP-01041
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by European Lung Cancer Working Party:
Randomised phase III
Advanced non-small cell lung carcinoma

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Isophosphamide mustard
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Alkylating
Alkylating Agents