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

Phase 3

Terminated

• Conditions: Non-small Cell Lung Carcinoma
• Interventions: Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel; Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

• Registration Number: NCT00633568
• Lead Sponsor: European Lung Cancer Working Party

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Primary Completion: 2014-12
• Status Verified: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel	One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy
B	Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel	Three courses of induction chemotherapy followed by consolidation chemoradiotherapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Local control rate	After completion of treatment
Response rate	At the end of the whole treatment
Toxicity	After each course of chemotherapy and at the end of treatment

Trial Locations

Locations (19)

Service de Pneumologie Centre Hospitalier de Douai; 🇫🇷 Douai, France

Service de Pneumologie Hôpital de Hayange; 🇫🇷 Hayange, France

Pneumology department of CHU Lille; 🇫🇷 Lille, France

Service de Pneumologie CHG Tourcoing; 🇫🇷 Tourcoing, France

Cabinet médical Saint-Michel; 🇫🇷 Valenciennes, France

Medical Oncology St Savas Hospital; 🇬🇷 Athens, Greece

Medical Oncology Hospital de Sagunto; 🇪🇸 Valencia, Spain

Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil; 🇫🇷 Montfermeil, France

Department of Pneumology Clinique Saint-Luc; 🇧🇪 Bouge, Belgium

Department of Pneumology Hospital Ixelles-Molière; 🇧🇪 Brussels, Belgium

CH Peltzer-La Tourelle; 🇧🇪 Verviers, Belgium

Department of Pneumology RHMS Hôpital de la Madeleine; 🇧🇪 Ath, Belgium

Department of Pneumology CHR St Joseph-Warquignies; 🇧🇪 Boussu, Belgium

Hôpital Ambroise Paré; 🇧🇪 Mons, Belgium

Department of Pneumology Centre Hospitalier de Mouscron; 🇧🇪 Mouscron, Belgium

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Department of Pneumology CHU Charleroi; 🇧🇪 Charleroi, Belgium

Department of Pneumology Hôpital Saint-Joseph; 🇧🇪 Gilly, Belgium

Hôpital Vésale - Montigny-le-Tilleul; 🇧🇪 Montigny-le-Tilleul, Belgium