Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate if the multi modality treatment pemetrexed combined with cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect profile in patients with locally advanced NSCLC. Patients will be randomized between 3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Antwerp
• Collaborators: Eli Lilly and Company; Universiteit Antwerpen
• Treatments: Cisplatin; Pemetrexed

Criteria

Inclusion Criteria:

• cytological or histological proven NSCLC

• unresectable stage III NSCLC

• presence of at least one measurable lesion (RECIST criteria)

• adequate haematological, renal and hepatic function

• adequate lung function reserve

• good condition, weight loss <10 % over previous 6 months, life expectancy > 3 months

Exclusion Criteria:

• previous chemo- or radiotherapy for NSCLC

• distant metastasis or a malignant pleural or pericardial effusion

• second active primary malignancy or serious concomitant medical disease

• interstitial lung disease

• auto-immune systemic disease with potential involvement of the lungs

• inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period

• concomitant use of amiodarone