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NCT00563160 Clinical Trial

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

Lung Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00563160
Other study ID # (193-h)in QE/EC/I
Secondary ID HARECCTR05000150
Status Recruiting
Phase Phase 2
First received November 21, 2007
Last updated July 6, 2010
Start date May 2005
Est. completion date February 2007

Study information
Verified date July 2010
Source Hospital Authority, Hong Kong
Contact Patricia Poon, Dr
Phone (852) 2958 2310
Email pcm0806@netvigator.com
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gemcitabine, carboplatin

Procedure:
• surgery

Locations
Country Name City State
China Queen Elizabeth Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary pathological response rate 12 months
Secondary progression-free survival 18 months
Secondary overall survival 18 months
Secondary quality of life measurements 18 months
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