Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer
This study has been completed.
Sponsor:
European Lung Cancer Working Party
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
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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:
Drug Information available for:
Ifosfamide
Cisplatin
Gemcitabine
Docetaxel
Gemcitabine hydrochloride
U.S. FDA Resources
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 May 23, 2013