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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563160
First Posted: November 26, 2007
Last Update Posted: July 7, 2010
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.
Collaborator:
Eli Lilly and Company
Information provided by:
Hospital Authority, Hong Kong
  Purpose
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 Intervention Phase
Lung Neoplasms Drug: gemcitabine, carboplatin Procedure: surgery Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

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

Secondary Outcome Measures:
  • progression-free survival [ Time Frame: 18 months ]
  • overall survival [ Time Frame: 18 months ]
  • quality of life measurements [ Time Frame: 18 months ]

Estimated Enrollment: 50
Study Start Date: May 2005
Estimated Study Completion Date: February 2007
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00563160


Contacts
Contact: Patricia Poon, Dr (852) 2958 2310 pcm0806@netvigator.com

Locations
China
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
Investigators
Principal Investigator: Siu Kie Au, Dr Department of Clinical Oncology, Queen Elizabeth Hospital
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00563160     History of Changes
Other Study ID Numbers: (193-h)in QE/EC/I
HARECCTR0500015
000904
B9E-IH-O333
First Submitted: November 21, 2007
First Posted: November 26, 2007
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs