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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00463515
First Posted: April 20, 2007
Last Update Posted: July 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universiteit Antwerpen
Eli Lilly and Company
Information provided by:
University Hospital, Antwerp
  Purpose
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
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

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463515


Locations
Belgium
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
Investigators
Principal Investigator: Paul R Germonpre Universiteit Antwerpen
  More Information

ClinicalTrials.gov Identifier: NCT00463515     History of Changes
Other Study ID Numbers: CHER@NOS
First Submitted: April 18, 2007
First Posted: April 20, 2007
Last Update Posted: July 12, 2013
Last Verified: July 2013

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

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