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

Non-small Cell Lung Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00633568
• Other study ID #: ELCWP 01063
• Status: Terminated
• Phase: Phase 3
• First received: March 5, 2008
• Last updated: February 11, 2015
• Start date: January 2007
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: European Lung Cancer Working Party
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentSpain: Ministry of HealthGreece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Carcinoma

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	Department of Pneumology RHMS Hôpital de la Madeleine	Ath
Belgium	Department of Pneumology Clinique Saint-Luc	Bouge
Belgium	Department of Pneumology CHR St Joseph-Warquignies	Boussu
Belgium	Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Brussels
Belgium	Department of Pneumology Hospital Ixelles-Molière	Brussels
Belgium	Department of Pneumology CHU Charleroi	Charleroi
Belgium	Department of Pneumology Hôpital Saint-Joseph	Gilly
Belgium	Hôpital Ambroise Paré	Mons
Belgium	Hôpital Vésale - Montigny-le-Tilleul	Montigny-le-Tilleul
Belgium	Department of Pneumology Centre Hospitalier de Mouscron	Mouscron
Belgium	CH Peltzer-La Tourelle	Verviers
France	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 Centre Hospitalier Intercommunal le Raincy-Montfermeil	Montfermeil
France	Service de Pneumologie CHG Tourcoing	Tourcoing
France	Cabinet médical Saint-Michel	Valenciennes
Greece	Medical Oncology St Savas Hospital	Athens
Spain	Medical Oncology Hospital de Sagunto	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
European Lung Cancer Working Party

Countries where clinical trial is conducted

Belgium,  France,  Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		Survival will be dated from the day of randomisation until death or last follow up	Yes
Secondary	Response rate		At the end of the whole treatment	No
Secondary	Toxicity		After each course of chemotherapy and at the end of treatment	No
Secondary	Local control rate		After completion of treatment	No

External Links

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