Status:
TERMINATED
Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer
Lead Sponsor:
European Lung Cancer Working Party
Conditions:
Non-small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as i...
Eligibility Criteria
Inclusion
- Histological or cytological diagnosis of non-small cell carcinoma of the lung
- 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
- Prior treatment with chemotherapy, radiotherapy or surgery
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00633568
Start Date
January 1 2007
End Date
February 1 2015
Last Update
February 12 2015
Active Locations (19)
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1
Department of Pneumology RHMS Hôpital de la Madeleine
Ath, Belgium, 7800
2
Department of Pneumology Clinique Saint-Luc
Bouge, Belgium, 5004
3
Department of Pneumology CHR St Joseph-Warquignies
Boussu, Belgium, 7360
4
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000