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

February 11, 2015 updated by: European Lung Cancer Working Party

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: Survival will be dated from the day of randomisation until death or last follow up
Survival will be dated from the day of randomisation until death or last follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: After each course of chemotherapy and at the end of treatment
After each course of chemotherapy and at the end of treatment
Response rate
Time Frame: At the end of the whole treatment
At the end of the whole treatment
Local control rate
Time Frame: After completion of treatment
After completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Lung Cancer Working Party

Investigators

  • Study Chair: Thierry Berghmans, MD, European Lung Cancer Working Party

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELCWP 01063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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