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Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small-cell Lung Cancer Before Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00563160
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : November 26, 2007
Last Update Posted : July 7, 2010
Eli Lilly and Company
Information provided by:
Hospital Authority, Hong Kong

Brief Summary:
To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis

Condition or disease Intervention/treatment Phase
Lung Neoplasms Drug: gemcitabine, carboplatin Procedure: surgery Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small Cell Lung Cancer Before Surgery
Study Start Date : May 2005
Estimated Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. pathological response rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 18 months ]
  2. overall survival [ Time Frame: 18 months ]
  3. quality of life measurements [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Histologically or cytologically proven, newly diagnosed primary bronchogenic non-small cell lung cancer
  • Measurable or evaluable tumour on chest X-ray or CT scan.
  • No multiple ipsilateral or contralateral parenchymal tumours
  • Stage I(exceptT1N0),II,IIIa disease as shown by PET-CT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00563160

Contact: Patricia Poon, Dr (852) 2958 2310

Queen Elizabeth Hospital Recruiting
Hong Kong, China
Sub-Investigator: Che Mun Poon, Dr         
Sub-Investigator: Chun Key Law, Dr         
Sub-Investigator: Roger Ngan, Dr         
Sub-Investigator: Chung Kong Kwan, Dr         
Sub-Investigator: Cheuk Kin Lo, Dr         
Sub-Investigator: Johnny Chan, Dr         
Sub-Investigator: TK Au Yong, Dr         
Sub-Investigator: Ting Lok Kwan, Dr         
Sub-Investigator: Stella Cheung, Dr         
Sub-Investigator: Timothy Yip         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Eli Lilly and Company
Principal Investigator: Siu Kie Au, Dr Department of Clinical Oncology, Queen Elizabeth Hospital

Additional Information: Identifier: NCT00563160     History of Changes
Other Study ID Numbers: (193-h)in QE/EC/I
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Hospital Authority, Hong Kong:
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs