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.

European Lung Cancer Working Party19 sites in 4 countries125 target enrollmentJanuary 2007

InterventionsConcomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

DrugsConcomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

Overview

Phase: Phase 3
Intervention: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Conditions: Non-small Cell Lung Carcinoma
Sponsor: European Lung Cancer Working Party
Enrollment: 125
Locations: 19
Primary Endpoint: Survival
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

February 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

European Lung Cancer Working Party

Responsible Party

Sponsor

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