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.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Carcinoma
• Intervention / Treatment: Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel; Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 3

Contacts and Locations

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
    • Hôpital Ambroise Paré
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Docetaxel; Cisplatin; Radiotherapy; Chemotherapy; Non-small cell lung carcinoma; Concomitant radiochemotherapy; Unresectable stage III non-small cell lung carcinoma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin
• Other Study ID Numbers: ELCWP 01063