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TerminatedNCT00633568Updated Feb 12, 2015

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

A Phase 3 interventional study of Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel and Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel in Non-small Cell Lung Carcinoma, sponsored by European Lung Cancer Working Party. Terminated at 19 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-12.

Sponsored by European Lung Cancer Working Party · Phase 3, Interventional, and Treatment

Why this study was terminated
Slow recruitment
Phase
Phase 3
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 induction followed by consolidation concurrent chemoradiotherapy.

02

Conditions studied

  • Non-small Cell Lung Carcinoma

Keywords

  • Non-small cell lung carcinoma
  • Concomitant radiochemotherapy
  • Cisplatin
  • Docetaxel
  • Radiotherapy
  • Chemotherapy
  • Unresectable stage III non-small cell lung carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 125 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

European Lung Cancer Working Party is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
125 participants (actual)

Study arms

  • 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

  • Experimental
    B

    Three courses of induction chemotherapy followed by consolidation chemoradiotherapy

    Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

Interventions

  • DrugConcomitant 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

  • DrugConcomitant 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

06

What researchers measure

Primary outcomes

  1. Survival

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

Secondary outcomes

  1. Response rate

    Time frame: At the end of the whole treatment

  2. Toxicity

    Time frame: After each course of chemotherapy and at the end of treatment

  3. Local control rate

    Time frame: After completion of treatment

07

Study locations

19 sites
  • Department of Pneumology RHMS Hôpital de la Madeleine
    Ath, 7800, Belgium
  • Department of Pneumology Clinique Saint-Luc
    Bouge, 5004, Belgium
  • Department of Pneumology CHR St Joseph-Warquignies
    Boussu, 7360, Belgium
  • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
    Brussels, 1000, Belgium
  • Department of Pneumology Hospital Ixelles-Molière
    Brussels, Belgium
  • Department of Pneumology CHU Charleroi
    Charleroi, Belgium
  • Department of Pneumology Hôpital Saint-Joseph
    Gilly, 6060, Belgium
  • Hôpital Ambroise Paré
    Mons, 7000, Belgium
  • Hôpital Vésale - Montigny-le-Tilleul
    Montigny-le-Tilleul, 6110, Belgium
  • Department of Pneumology Centre Hospitalier de Mouscron
    Mouscron, 7700, Belgium
  • CH Peltzer-La Tourelle
    Verviers, 4800, Belgium
  • Service de Pneumologie Centre Hospitalier de Douai
    Douai, 59507, France
  • Service de Pneumologie Hôpital de Hayange
    Hayange, 57700, France
  • Pneumology department of CHU Lille
    Lille, France
  • Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil
    Montfermeil, 93370, France
  • Service de Pneumologie CHG Tourcoing
    Tourcoing, 59208, France
  • Cabinet médical Saint-Michel
    Valenciennes, 59300, France
  • Medical Oncology St Savas Hospital
    Athens, 11522, Greece
  • Medical Oncology Hospital de Sagunto
    Valencia, Spain
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00633568
Lead sponsor
European Lung Cancer Working Party
Responsible party
Sponsor
First posted
Mar 12, 2008
Start date
Jan 2007
Primary completion
Dec 2014
Completion
Feb 2015
Last update
Feb 12, 2015

Study contacts

Thierry Berghmans, MD
study chair · European Lung Cancer Working Party

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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