A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-resectable Stage III Non-Small-Cell-Lung Cancer

University Hospital, Antwerp3 sites in 1 country77 target enrollmentJanuary 2003

ConditionsNon-Small-Cell-Lung Cancer

Drugscarboplatin/gemcitabine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non-Small-Cell-Lung Cancer
Sponsor: University Hospital, Antwerp
Enrollment: 77
Locations: 3
Primary Endpoint: 2-year survival rates
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

November 2006

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Antwerp

Eligibility 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