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

This study has been completed.
Universiteit Antwerpen
Eli Lilly and Company
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
First received: April 18, 2007
Last updated: July 11, 2013
Last verified: July 2013
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 Intervention Phase
Non-Small-Cell-Lung Cancer
Drug: carboplatin/gemcitabine
Procedure: cisplatin/radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Antwerp:

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

Estimated Enrollment: 77
Study Start Date: January 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00463515

ZNA Middelheim
Antwerpen, Antwerp, Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium
Sint Augustinus Ziekenhuis
Wilrijk, Antwerp, Belgium
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Eli Lilly and Company
Principal Investigator: Paul R Germonpre Universiteit Antwerpen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00463515     History of Changes
Other Study ID Numbers: CHER@NOS 
Study First Received: April 18, 2007
Last Updated: July 11, 2013
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by University Hospital, Antwerp:
Non-Small Cell Lung Cancer
lung cancer
induction chemotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 04, 2016