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NCT Number: NCT00463515

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

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.

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Key information

Conditions

Non-Small-Cell-Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ZNA Middelheim, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin/gemcitabine

Drug

cisplatin/radiation therapy

Procedure

Primary outcomes

  1. 2-year survival rates

Secondary outcomes

  1. Response rate

  2. Time to intrathoracic failure

  3. Overall survival

  4. Toxicity of induction chemotherapy

  5. Toxicity of chemo-radiotherapy

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Eli Lilly and Company
  • Universiteit Antwerpen

Registry information

Official study 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

Acronym: CHER@NOS

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Apr 20, 2007
Registry last updated
Jul 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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