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

Phase 2

Completed

• Conditions: Non-Small-Cell-Lung Cancer

• Registration Number: NCT00463515
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-11
• Last Update Posted: 2013-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
2-year survival rates

Secondary Outcome Measures

Name	Time	Method
Response rate
Time to intrathoracic failure
Overall survival
Toxicity of induction chemotherapy
Toxicity of chemo-radiotherapy

Trial Locations

Locations (3)

ZNA Middelheim; 🇧🇪 Antwerpen, Antwerp, Belgium

Sint Augustinus Ziekenhuis; 🇧🇪 Wilrijk, Antwerp, Belgium

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium