Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer
NCT ID: NCT00633568
Last Updated: 2015-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
125 participants
INTERVENTIONAL
2007-01-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy
Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
B
Three courses of induction chemotherapy followed by consolidation chemoradiotherapy
Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
Interventions
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Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
Eligibility Criteria
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Inclusion Criteria
* Initially unresectable non-metastatic stage III disease
* Availability for participating in the detailed follow-up of the protocol
* Presence of an evaluable or measurable lesion
* Written informed consent
* No functional or anatomical contraindication to chest irradiation
Exclusion Criteria
* Performance status \< 60 on the Karnofsky scale
* History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
* Neutrophils \< 2,000/mm³
* Platelet cells \< 100,000/mm3
* Serum bilirubin \> 1.5 mg/100 ml
* Hepatic disease contra-indicating the administration of docetaxel and/or GOT or GPT ≥ 2.5x the normal value and/or alkaline phosphatase ≥ 5x the normal value
* Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min
* Recent myocardial infarction (less than 3 months prior to date of diagnosis) or uncontrolled angina pectoris
* Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
* Uncontrolled infectious disease
* Symptomatic polyneuropathy
* Auditive impairment contra-indicating cisplatin administration
* Serious medical or psychological factors which may prevent adherence to the treatment schedule
* Malignant pleural or pericardial effusion
* Homolateral supraclavicular lymph node excepting upper lobe lesion
* Heterolateral supraclavicular lymph node
* Known hypersensitivity to docetaxel or cisplatin
* Pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive method
18 Years
ALL
No
Sponsors
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European Lung Cancer Working Party
OTHER
Responsible Party
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Principal Investigators
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Thierry Berghmans, MD
Role: STUDY_CHAIR
European Lung Cancer Working Party
Locations
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Department of Pneumology RHMS Hôpital de la Madeleine
Ath, , Belgium
Department of Pneumology Clinique Saint-Luc
Bouge, , Belgium
Department of Pneumology CHR St Joseph-Warquignies
Boussu, , Belgium
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, , Belgium
Department of Pneumology Hospital Ixelles-Molière
Brussels, , Belgium
Department of Pneumology CHU Charleroi
Charleroi, , Belgium
Department of Pneumology Hôpital Saint-Joseph
Gilly, , Belgium
Hôpital Ambroise Paré
Mons, , Belgium
Hôpital Vésale - Montigny-le-Tilleul
Montigny-le-Tilleul, , Belgium
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, , Belgium
CH Peltzer-La Tourelle
Verviers, , Belgium
Service de Pneumologie Centre Hospitalier de Douai
Douai, , France
Service de Pneumologie Hôpital de Hayange
Hayange, , France
Pneumology department of CHU Lille
Lille, , France
Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil
Montfermeil, , France
Service de Pneumologie CHG Tourcoing
Tourcoing, , France
Cabinet médical Saint-Michel
Valenciennes, , France
Medical Oncology St Savas Hospital
Athens, , Greece
Medical Oncology Hospital de Sagunto
Valencia, , Spain
Countries
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Related Links
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Click here for more information on the protocol
Other Identifiers
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ELCWP 01063
Identifier Type: -
Identifier Source: org_study_id
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