Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy

Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy

The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.

This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.

Inclusion Criteria:

• Histological or cytological diagnosis of NSCLC stage IIIA-B.
• Nonresectable or medically inoperable patients.
• No prior chemo- or radiotherapy for NSCLC.
• PS 0-1.
• FEV1 > 1 l or > 40% and CO diffusion capacity > 40%.
• Patient compliance and geographic proximity that allow adequate follow-up.
• Adequate bone marrow reserve: WBCC >3.0, platelets >100, haemoglobin > 100.
• Written informed concent.
• Effective use of contraception.

Exclusion Criteria:

• Excessive weight loss within 6 months (> 10%).
• Supraclavicular nodes.
• Apical tumors-pancoast.
• T4 tumors with separate manifestations in different lobes.
• Evidence of active serious infections.
• Inadequate liver function.
• Inadequate kidney function.
• Pregnancy.
• Breast feeding.
• Serious concomitant systemic disorder.
• Second primary malignancy the last 5 years.