Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-Resectable Stage III NSCLC (CHER@NOS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University Hospital, Antwerp.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University Hospital, Antwerp
Collaborators:
Thoracic Oncology Group Antwerp
Eli Lilly and Company
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00463515
First received: April 18, 2007
Last updated: April 19, 2007
Last verified: April 2007
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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 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 |
| Estimated Study Completion Date: | April 2008 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Thoracic Oncology Group Antwerp
Eli Lilly and Company
Investigators
| Principal Investigator: | Paul R Germonpre | Thoracic Oncology Group Antwerp |
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: | April 19, 2007 |
| 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 NSCLC Chemoradiation |
lung cancer induction chemotherapy chemo-radiotherapy |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Cisplatin Carboplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013