Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3 cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic progression of disease. The induction chemotherapy is then to be followed by chemo-radiotherapy.

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

Details

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

Criteria

Inclusion Criteria:

• cytological or histologically 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 chemotherapy for NSCLC

• distant metastasis or a pleural or pericardial effusion

• treatment for malignant disease in the past or serious concomitant medical or psychiatric disease

• active uncontrolled infection at time of inclusion

• interstitial lung disease

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

• concomitant use of amiodarone