Non-Small-Cell-Lung Cancer Clinical Trial
— CHER@NOSOfficial title:
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
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.
Status | Completed |
Enrollment | 77 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | ZNA Middelheim | Antwerpen | Antwerp |
Belgium | University Hospital Antwerp | Edegem | Antwerp |
Belgium | Sint Augustinus Ziekenhuis | Wilrijk | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | Eli Lilly and Company, Universiteit Antwerpen |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-year survival rates | |||
Secondary | Response rate | |||
Secondary | Time to intrathoracic failure | |||
Secondary | Overall survival | |||
Secondary | Toxicity of induction chemotherapy | |||
Secondary | Toxicity of chemo-radiotherapy |