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

European Lung Cancer Working Party

Status and phase: Terminated; Phase 3

Conditions: Non-small Cell Lung Carcinoma

Treatments: Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel; Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00633568

ELCWP 01063

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

A

Active Comparator group

Description:

One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy

Treatment:

Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

B

Experimental group

Description:

Three courses of induction chemotherapy followed by consolidation chemoradiotherapy

Treatment:

Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel