HAREC Clinical Trial Registry Record
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Title for Public Study of efficacy of induction chemotherapy with gemcitabine and carboplatin for operable non-small-cell lung cancer before surgery
HAREC ID HARECCTR0500015
Scientific 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

Trial ID
HA REC Trial ID (193-h)in QE/EC/I
Name of CREC REC (KC/KE)

Other Trial IDs
ID Number 000904
Issuing Authority Pharmacy and Poisons Board, Dept of Health, Hong Kong
 
ID Number B9E-IH-O333
Issuing Authority Eli Lilly Asia,INC.
 
Lead Principal Investigator
Name Dr   Siu Kie   Au
Department/Unit Department of Clinical Oncology
Institute/Hospital Queen Elizabeth Hospital

Contact person
Name Dr   Patricia   Poon
Department/Unit Department of Clinical Oncology
Institute/Hospital Queen Elizabeth Hospital
Phone 29582310
Fax 23594782
Internet Mail pcm0806@netvigator.com

Disease/s or Condition/s
lung cancer

Intervention/s
Intervention 1
Intervention Name gemcitabine, carboplatin
Type of Intervention Drug
Duration 6 Weeks
Other details total of 2 cycles of chemotherapy given
Active Control NO
Intervention 2
Intervention Name surgery
Type of Intervention Procedure
Duration 1 Day
Other details
Active Control NO

Inclusion and Exclusion Criteria
Gender Non-specific
Age 18-75 years old
Inclusion and Exclusion Criteria 1. Histologically or cytologically proven, newly diagnosed primary bronchogenic non-small cell lung cancer 2. Measurable or evaluable tumour on chest X-ray or CT scan. 3.No multiple ipsilateral or contralateral parenchymal tumours 4. Stage I(exceptT1N0),II,IIIa disease as shown by PET-CT

Study Type Interventional
Purpose Treatment
Allocation Nonrandomized trial
Masking Open (masking not used)
Control Uncontrolled
Assignment Single group
Endpoint Efficacy

Primary Outcome/s
Outcome name pathological response rate
Timepoint 12 months

Secondary Outcome/s
Outcome name progression-free survival
Timepoint 18 months
Outcome name overall survival
Timepoint 18 months
Outcome name quality of life measurements
Timepoint 18 months

Date of First Enrollment 2005-05-19
(yyyy-mm-dd)

Target Sample Size 50

Recruitment Status Recruiting

Funding Source/s
Name Eli Lilly Asia,INC
Address or contact information 27th Floor, CITIC Tower, 1, Tim Mei Avenue, Central, Hong Kong

Primary Sponsor
Name Hospital Authority
Address or contact information Dr Au Siu Kie, Room 1108, Block R, Department of Clinical Oncology, Queen Elizabeth Hospital, Kowloon

Secondary Sponsor
Name Eli Lilly Asia,INC
Address or contact information 27th Floor, CITIC Tower, 1, Tim Mei Avenue, Central, Hong Kong

Research Ethics Board/Committee Approval YES

Co-Investigator/s
Name Dr Che Mun Poon
Department Clinical Oncology
Organization Queen Elizabeth Hospital

Name Dr Chun Key Law
Department Clinical Oncology
Organization Queen Elizabeth Hospital

Name Dr Roger Ngan
Department Clinical Oncology
Organization Queen Elizabeth Hospital

Name Dr Chung Kong Kwan
Department Clinical Oncology
Organization Queen Elizabeth Hospital

Name Dr Cheuk Kin Lo
Department Cardiothoracic Surgery
Organization Queen Elizabeth Hospital

Name Dr Johnny Chan
Department Respiratory Medicine
Organization Queen Elizabeth Hospital

Name Dr TK Au Yong
Department Nuclear Medicine
Organization Queen Elizabeth Hospital

Name Dr Ting Lok Kwan
Department Diagnostic Radiology
Organization Queen Elizabeth Hospital

Name Dr Stella Cheung
Department Anatomical and Clinical Pathology
Organization Queen Elizabeth Hospital

Name Mr Timothy Yip
Department Clinical Oncology
Organization Queen Elizabeth Hospital


Study Site/s
Local site/s Department Organization
1 Clinical Oncology Queen Elizabeth Hospital

Clinical Specialty Clinical Oncology

Proposed Date of Last Follow-up 2007-02-28
(yyyy-mm-dd)

Registration Date 2005-09-12
(yyyy-mm-dd)

Submission Date 2005-09-09
(yyyy-mm-dd)

Record Status Verified; registration accepted - complete data. October 2005