Study of Efficacy of Induction Chemotherapy With Gemcitab... | NCT00563160

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

NCT00563160

Sponsor

Hospital Authority, Hong Kong

Status

Unknown status

Last Update Posted

Jul 7, 2010Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Lung Neoplasms

Interventions

gemcitabine, carboplatin
surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Not provided

Completion Date

Feb 2007Estimated

First Submitted Date

Nov 21, 2007

First Submission Date that Met QC Criteria

Nov 23, 2007

First Posted Date

Nov 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2010

Last Update Posted Date

Jul 7, 2010Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pathological response rate		12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patricia Poon, Dr	Contact	(852) 2958 2310		pcm0806@netvigator.com

Overall Officials

Name	Affiliation	Role
Siu Kie Au, Dr	Department of Clinical Oncology, Queen Elizabeth Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Elizabeth Hospital	Recruiting	Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
D016190	Carboplatin
D013514	Surgical Procedures, Operative

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
HARECCTR0500015
000904
B9E-IH-O333

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine, carboplatin	Drug
surgery	Procedure