Status:
UNKNOWN
Individualized Chemotherapy Based on BRCA1 and RRM1 mRNA for Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Tongji University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Gemcitabine, docetaxel, CPT-11 and cisplatin are effective in 1st line treatment of advanced non-small cell lung cancer (NSCLC). Platinum-based doublets including gemcitabine, docetaxel or CPT-11 are ...
Detailed Description
Primary end point:ORR Secondary end point:PFS,OS,safety,QOL,etc.
Eligibility Criteria
Inclusion
- Written informed consent,
- Histologically confirmed stage M1a or M1b NSCLC,
- Aged over 18 years old,
- Measurable disease,
- Life expectancy of at least 12 weeks,
- No prior chemotherapy or target therapy,
- No brain metastases or spinal cord compression,
- Less than 10% body weight loss,
- ECOG performance status 0-2,
- Adequate vital organ function (haematological, renal, hepatic, etc).
- Enough tissue for detection of BRCA1 and RRM1 expression.
Exclusion
- Prior systemic cytotoxic chemotherapy or EGFR TKI therapy,
- Positive pregnancy test,
- Another active malignancy, other than superficial basal cell and squamous cell or carcinoma in situ of the cervix, within the last 5 years,
- Patients with brain metastases or spinal cord compression,
- Allergy to gemcitabine, cisplatin, docetaxel, CPT-11,
- Any unstable systemic disease including active infection,
- No enough tissue for detection of BRCA1 and RRM1
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01424709
Start Date
December 1 2010
End Date
December 1 2014
Last Update
September 25 2014
Active Locations (1)
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1
Medical Department, Shanghai Pulmonary Hospital
Shanghai, China, 200433