Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014