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

Phase 1

• Conditions: nresectable non metastatic stage III non small cell lung carcinoma eligible for concomitant radiochemotherapy; MedDRA version: 9.1Level: HLGTClassification code 10038666Term: Respiratory and mediastinal neoplasms malignant and unspecified

• Registration Number: EUCTR2006-004726-91-FR
• Lead Sponsor: CHRU de Lille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-19
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

- Men or women aged = 18 years old
- 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
- Irradiation technically possible

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Prior treatment with chemotherapy, radiotherapy or surgery
- Performance status < 60 on the Karnofsky scale
- A 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
- Allergy or known hypersensitivity to docetaxel or cisplatin
- Women of child bearing potential not consenting to use adequate contraceptive precautions
- Female subject who is pregnant or breastfeeding
- Aberrations from the radiotherapy guidelines

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison to induction chemotherapy followed by consolidation concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer;Secondary Objective: - to determine the objective response rate between the two therapeutic approaches<br>- to determine the toxicity between the two therapeutic approaches<br>- to determine the local control rate obtained in each arm<br>;Primary end point(s): The primary endpoint of the study will be to compare the distributions of the survival duration between the two arms.