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

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
NCT00633568
First received: March 5, 2008
Last updated: February 11, 2015
Last verified: February 2015
  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 ]

Enrollment: 125
Study Start Date: January 2007
Study Completion Date: February 2015
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

Locations
Belgium
Department of Pneumology RHMS Hôpital de la Madeleine
Ath, Belgium, 7800
Department of Pneumology Clinique Saint-Luc
Bouge, Belgium, 5004
Department of Pneumology CHR St Joseph-Warquignies
Boussu, Belgium, 7360
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
Department of Pneumology Hospital Ixelles-Molière
Brussels, Belgium
Department of Pneumology CHU Charleroi
Charleroi, Belgium
Department of Pneumology Hôpital Saint-Joseph
Gilly, Belgium, 6060
Hôpital Ambroise Paré
Mons, Belgium, 7000
Hôpital Vésale - Montigny-le-Tilleul
Montigny-le-Tilleul, Belgium, 6110
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, Belgium, 7700
CH Peltzer-La Tourelle
Verviers, Belgium, 4800
France
Service de Pneumologie Centre Hospitalier de Douai
Douai, France, 59507
Service de Pneumologie Hôpital de Hayange
Hayange, France, 57700
Pneumology department of CHU Lille
Lille, France
Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil
Montfermeil, France, 93370
Service de Pneumologie CHG Tourcoing
Tourcoing, France, 59208
Cabinet médical Saint-Michel
Valenciennes, France, 59300
Greece
Medical Oncology St Savas Hospital
Athens, Greece, 11522
Spain
Medical Oncology Hospital de Sagunto
Valencia, Spain
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: February 11, 2015
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, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
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 July 27, 2015