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

This study has been completed.
Sponsor:
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: July 11, 2013
Last verified: July 2013
  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
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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
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 July 24, 2014