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

Primary Purpose

Non-Small-Cell-Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
carboplatin/gemcitabine
cisplatin/radiation therapy
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell-Lung Cancer focused on measuring Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, lung cancer, induction chemotherapy, chemo-radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ZNA Middelheim
  • University Hospital Antwerp
  • Sint Augustinus Ziekenhuis

Outcomes

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

Full Information

First Posted
April 18, 2007
Last Updated
July 11, 2013
Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00463515
Brief Title
Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC
Acronym
CHER@NOS
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen, Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell-Lung Cancer
Keywords
Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, lung cancer, induction chemotherapy, chemo-radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin/gemcitabine
Intervention Type
Procedure
Intervention Name(s)
cisplatin/radiation therapy
Primary Outcome Measure Information:
Title
2-year survival rates
Secondary Outcome Measure Information:
Title
Response rate
Title
Time to intrathoracic failure
Title
Overall survival
Title
Toxicity of induction chemotherapy
Title
Toxicity of chemo-radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul R Germonpre
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZNA Middelheim
City
Antwerpen
State/Province
Antwerp
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
Country
Belgium
Facility Name
Sint Augustinus Ziekenhuis
City
Wilrijk
State/Province
Antwerp
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC

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