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Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer

This study is currently recruiting participants.
Verified January 2013 by European Lung Cancer Working Party
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
NCT00633568
First received: March 5, 2008
Last updated: January 28, 2013
Last verified: January 2013
History of Changes

March 5, 2008
January 28, 2013
January 2007
December 2014   (final data collection date for primary outcome measure)
Survival [ Time Frame: Survival will be dated from the day of randomisation until death or last follow up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00633568 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: At the end of the whole treatment ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: After each course of chemotherapy and at the end of treatment ] [ Designated as safety issue: No ]
  • Local control rate [ Time Frame: After completion of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer
A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.

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 induction followed by consolidation concurrent chemoradiotherapy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Carcinoma
  • Drug: 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
  • Drug: 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
  • Active Comparator: A
    One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy
    Intervention: Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
  • Experimental: B
    Three courses of induction chemotherapy followed by consolidation chemoradiotherapy
    Intervention: Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
246
June 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
No
Contact: Nathalie Leclercq, RN 0032/2/5390496 nathalie.leclercq@bordet.be
Contact: Thierry Berghmans, MD 0032/2/5390496
Belgium,   France,   Greece,   Spain
 
NCT00633568
ELCWP 01063
Yes
European Lung Cancer Working Party
European Lung Cancer Working Party
Not Provided
Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party
European Lung Cancer Working Party
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP