Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC (CHER@NOS)

Antwerp University Hospital (UZA)

Status and phase

Completed

Phase 2

Conditions

Non-Small-Cell-Lung Cancer

Treatments

Drug: carboplatin/gemcitabine

Procedure: cisplatin/radiation therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00463515

CHER@NOS

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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