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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Carcinoma
Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and 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 Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable 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 day of randomisation until death or last follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 246
Study Start Date: January 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy
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
Experimental: B
Three courses of induction chemotherapy followed by consolidation chemoradiotherapy
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

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633568

Contacts
Contact: Nathalie Leclercq, RN 0032/2/5390496 nathalie.leclercq@bordet.be
Contact: Thierry Berghmans, MD 0032/2/5390496

Locations
Belgium
Department of Pneumology RHMS Hôpital de la Madeleine Recruiting
Ath, Belgium, 7800
Contact: Pol Ravez, MD         
Principal Investigator: Pol Ravez, MD         
Department of Pneumology Clinique Saint-Luc Recruiting
Bouge, Belgium, 5004
Contact: Oswald Van Cutsem, MD         
Principal Investigator: Oswald Van Cutsem, MD         
Department of Pneumology CHR St Joseph-Warquignies Recruiting
Boussu, Belgium, 7360
Contact: Michel Richez, MD         
Principal Investigator: Michel Richez, MD         
Department of Pneumology Hospital Ixelles-Molière Recruiting
Brussels, Belgium
Contact: Saida Benslimane, MD         
Principal Investigator: Saida Benslimane, MD         
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Thierry Berghmans, MD    0032/2/5390496      
Principal Investigator: Thierry Berghmans, MD         
Department of Pneumology CHU Charleroi Recruiting
Charleroi, Belgium
Contact: Jacques Lecomte, MD         
Principal Investigator: Jacques Lecomte, MD         
Department of Pneumology Hôpital Saint-Joseph Recruiting
Gilly, Belgium, 6060
Contact: Benoît Colinet, MD         
Principal Investigator: Benoît Colinet, MD         
Hôpital Ambroise Paré Recruiting
Mons, Belgium, 7000
Contact: Patricia Wackenier, MD         
Principal Investigator: Patricia Wackenier, MD         
Sub-Investigator: Stéphane Holbrechts, MD         
Hôpital Vésale - Montigny-le-Tilleul Recruiting
Montigny-le-Tilleul, Belgium, 6110
Contact: Dany Brohee, MD         
Principal Investigator: Dany Brohee, MD         
Department of Pneumology Centre Hospitalier de Mouscron Recruiting
Mouscron, Belgium, 7700
Contact: Christian Tulippe, MD         
Principal Investigator: Christian Tulippe, MD         
CH Peltzer-La Tourelle Recruiting
Verviers, Belgium, 4800
Contact: Yves Bonduelle, MD         
Principal Investigator: Yves Bonduelle, MD         
Sub-Investigator: Ingrid Louviaux, MD         
France
Service de Pneumologie Centre Hospitalier de Douai Recruiting
Douai, France, 59507
Contact: Marie-Chantal Florin, MD         
Principal Investigator: Marie-Chantal Florin, MD         
Service de Pneumologie Hôpital de Hayange Recruiting
Hayange, France, 57700
Contact: Marie-Claude Berchier, MD         
Principal Investigator: Marie-Claude Berchier, MD         
Pneumology department of CHU Lille Recruiting
Lille, France
Contact: Jean-Jacques Lafitte         
Principal Investigator: Jean-Jacques Lafitte, MD, PhD         
Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil Recruiting
Montfermeil, France, 93370
Contact: Thierry Collon, MD         
Principal Investigator: Thierry Collon, MD         
Service de Pneumologie CHG Tourcoing Recruiting
Tourcoing, France, 59208
Contact: Xavier Ficheroulle, MD         
Principal Investigator: Xavier Ficheroulle, MD         
Cabinet médical Saint-Michel Recruiting
Valenciennes, France, 59300
Contact: Bruno Stach, MD         
Principal Investigator: Bruno Stach, MD         
Greece
Medical Oncology St Savas Hospital Recruiting
Athens, Greece, 11522
Contact: Anna Efremidis, MD         
Principal Investigator: Anna Efremidis, MD         
Spain
Medical Oncology Hospital de Sagunto Recruiting
Valencia, Spain
Contact: Vicente Giner, MD    0034/96/2659405      
Principal Investigator: Vicente Giner, MD         
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party
  More Information

Additional Information:
No publications provided

Responsible Party: European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT00633568     History of Changes
Other Study ID Numbers: ELCWP 01063
Study First Received: March 5, 2008
Last Updated: January 28, 2013
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Spain: Ministry of Health
Greece: Ministry of Health and Welfare

Keywords provided by European Lung Cancer Working Party:
Non-small cell lung carcinoma
Concomitant radiochemotherapy
Cisplatin
Docetaxel
Radiotherapy
Chemotherapy
Unresectable stage III non-small cell lung carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014