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

Primary Purpose

Lung Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

gemcitabine, carboplatin

surgery

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

Queen Elizabeth HospitalRecruiting

Outcomes

Primary Outcome Measures

pathological response rate

Secondary Outcome Measures

progression-free survival

overall survival

quality of life measurements

Full Information

NCT ID

NCT00563160

First Posted

November 21, 2007

Last Updated

July 6, 2010

Sponsor

Hospital Authority, Hong Kong

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00563160

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

May 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Authority, Hong Kong

Collaborators

Eli Lilly and Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

Keywords

lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

gemcitabine, carboplatin

Intervention Type

Procedure

Intervention Name(s)

surgery

Primary Outcome Measure Information:

Title

pathological response rate

Time Frame

12 months

Secondary Outcome Measure Information:

Title

progression-free survival

Time Frame

18 months

Title

overall survival

Time Frame

18 months

Title

quality of life measurements

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patricia Poon, Dr

Phone

(852) 2958 2310

pcm0806@netvigator.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Siu Kie Au, Dr

Organizational Affiliation

Department of Clinical Oncology, Queen Elizabeth Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Elizabeth Hospital

City

Hong Kong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Che Mun Poon, Dr

First Name & Middle Initial & Last Name & Degree

Chun Key Law, Dr

First Name & Middle Initial & Last Name & Degree

Roger Ngan, Dr

First Name & Middle Initial & Last Name & Degree

Chung Kong Kwan, Dr

First Name & Middle Initial & Last Name & Degree

Cheuk Kin Lo, Dr

First Name & Middle Initial & Last Name & Degree

Johnny Chan, Dr

First Name & Middle Initial & Last Name & Degree

TK Au Yong, Dr

First Name & Middle Initial & Last Name & Degree

Ting Lok Kwan, Dr

First Name & Middle Initial & Last Name & Degree

Stella Cheung, Dr

First Name & Middle Initial & Last Name & Degree

Timothy Yip

12. IPD Sharing Statement

Learn more about this trial

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

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