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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
NCT00622349
First received: February 14, 2008
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Cisplatin, Ifosfamide, Gemcitabine
Drug: Ifosfamide, Gemcitabine
Drug: Cisplatin, docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:
  • Survival [ Time Frame: Survival will be dated from the first day of registration until death or last follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: Every 3 courses of chemotherapy ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: After each course of chemotherapy ] [ Designated as safety issue: No ]
  • Activity of second-line chemotherapy [ Time Frame: Every 3 courses of chemotherapy ] [ Designated as safety issue: No ]

Enrollment: 707
Study Start Date: February 2004
Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622349

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

Additional Information:
No publications provided

Responsible Party: European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT00622349     History of Changes
Other Study ID Numbers: ELCWP-01041
Study First Received: February 14, 2008
Last Updated: January 29, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Isophosphamide mustard
Gemcitabine
Docetaxel
Cisplatin
Ifosfamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 17, 2014