Clinical trial NCT00633568: Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: 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
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Survival
timeFrame: Survival will be dated from the day of randomisation until death or last follow up
Secondary outcomes:
measure: Response rate
timeFrame: At the end of the whole treatment
measure: Toxicity
timeFrame: After each course of chemotherapy and at the end of treatment
measure: Local control rate
timeFrame: After completion of treatment
Other outcomes:
Locations:
city: Ath
country: Belgium
facility: Department of Pneumology RHMS Hôpital de la Madeleine
city: Bouge
country: Belgium
facility: Department of Pneumology Clinique Saint-Luc
city: Boussu
country: Belgium
facility: Department of Pneumology CHR St Joseph-Warquignies
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Brussels
country: Belgium
facility: Department of Pneumology Hospital Ixelles-Molière
city: Charleroi
country: Belgium
facility: Department of Pneumology CHU Charleroi
city: Gilly
country: Belgium
facility: Department of Pneumology Hôpital Saint-Joseph
city: Mons
country: Belgium
facility: Hôpital Ambroise Paré
city: Montigny-le-Tilleul
country: Belgium
facility: Hôpital Vésale - Montigny-le-Tilleul
city: Mouscron
country: Belgium
facility: Department of Pneumology Centre Hospitalier de Mouscron
city: Verviers
country: Belgium
facility: CH Peltzer-La Tourelle
city: Douai
country: France
facility: Service de Pneumologie Centre Hospitalier de Douai
city: Hayange
country: France
facility: Service de Pneumologie Hôpital de Hayange
city: Lille
country: France
facility: Pneumology department of CHU Lille
city: Montfermeil
country: France
facility: Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil
city: Tourcoing
country: France
facility: Service de Pneumologie CHG Tourcoing
city: Valenciennes
country: France
facility: Cabinet médical Saint-Michel
city: Athens
country: Greece
facility: Medical Oncology St Savas Hospital
city: Valencia
country: Spain
facility: Medical Oncology Hospital de Sagunto
Study officials:
affiliation: European Lung Cancer Working Party
name: Thierry Berghmans, MD
role: STUDY_CHAIR
References: