- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00463515
Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC (CHER@NOS)
July 11, 2013 updated by: University Hospital, Antwerp
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
77
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Antwerp
-
Antwerpen, Antwerp, Belgium
- ZNA Middelheim
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Edegem, Antwerp, Belgium
- University Hospital Antwerp
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Wilrijk, Antwerp, Belgium
- Sint Augustinus Ziekenhuis
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
2-year survival rates
|
Secondary Outcome Measures
Outcome Measure |
---|
Response rate
|
Overall survival
|
Time to intrathoracic failure
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Toxicity of induction chemotherapy
|
Toxicity of chemo-radiotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul R Germonpre, Universiteit Antwerpen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
April 18, 2007
First Submitted That Met QC Criteria
April 19, 2007
First Posted (Estimate)
April 20, 2007
Study Record Updates
Last Update Posted (Estimate)
July 12, 2013
Last Update Submitted That Met QC Criteria
July 11, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Carboplatin
Other Study ID Numbers
- CHER@NOS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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