Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-Small-Cell Lung Cancer Before Surgery - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 21, 2007

Last Updated Date

December 15, 2008

Start Date ^†

May 2005

Current Primary Outcome Measures ^†

pathological response rate [ Time Frame: 12 months ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00563160 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Lung Neoplasms

Intervention ^†

Drug: gemcitabine, carboplatin
Procedure: surgery

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

February 2007

Primary Completion Date

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Patricia Poon, Dr

(852) 2958 2310

pcm0806@netvigator.com

Location Countries ^†

China

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00563160

Responsible Party

Secondary IDs ^††

HARECCTR0500015, 000904, B9E-IH-O333

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

Information Provided By

Hospital Authority, Hong Kong

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.