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

July 6, 2010 updated by: Hospital Authority, Hong Kong

Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small Cell Lung Cancer Before Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Queen Elizabeth Hospital
        • Sub-Investigator:
          • Roger Ngan, Dr
        • Sub-Investigator:
          • Che Mun Poon, Dr
        • Sub-Investigator:
          • Chun Key Law, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pathological response rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 18 months
18 months
overall survival
Time Frame: 18 months
18 months
quality of life measurements
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Siu Kie Au, Dr, Department of Clinical Oncology, Queen Elizabeth Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Anticipated)

February 1, 2007

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 23, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (193-h)in QE/EC/I
  • HARECCTR0500015
  • 000904
  • B9E-IH-O333

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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