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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 because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563160
First received: November 21, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
HAREC Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00563160     History of Changes
Other Study ID Numbers: (193-h)in QE/EC/I, HARECCTR0500015, 000904, B9E-IH-O333
Study First Received: November 21, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
lung cancer

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

ClinicalTrials.gov processed this record on May 23, 2013