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

Non-Small-Cell-Lung Cancer Clinical Trial

— CHER@NOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463515
• Other study ID #: CHER@NOS
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2007
• Last updated: July 11, 2013
• Start date: January 2003
• Est. completion date: November 2006

Study information

• Verified date: July 2013
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell-Lung Cancer

Intervention

Drug:
• carboplatin/gemcitabine

Procedure:
• cisplatin/radiation therapy

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen	Antwerp
Belgium	University Hospital Antwerp	Edegem	Antwerp
Belgium	Sint Augustinus Ziekenhuis	Wilrijk	Antwerp

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Eli Lilly and Company, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

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