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

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Completed

CT.gov ID

NCT00463515

Collaborator

Universiteit Antwerpen (Other), Eli Lilly and Company (Industry)

Enrollment

Locations

Duration (Months)

25.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell-Lung Cancer	Drug: carboplatin/gemcitabine Procedure: cisplatin/radiation therapy	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

2-year survival rates []

Secondary Outcome Measures

Response rate []
Time to intrathoracic failure []
Overall survival []
Toxicity of induction chemotherapy []
Toxicity of chemo-radiotherapy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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