Status:
COMPLETED
Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in NSCLC
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
The epidermal growth factor receptor (EGFR) has become an important target for cancer therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an important role in the treat...
Detailed Description
Not suitable: no more information is needed to be described.
Eligibility Criteria
Inclusion
- Histologically proven NSCLC diagnosis
- Life expectancy over four weeks
- absolute neutrophil count ≥ 2.0X109/L, Pt ≥ 100X109/L, hemoglobin ≥ 90g/l
- With normal hepatic function(AST, ALT \< 2.5 x upper limit of normal , and Total bilirubin ≤ upper limit of normal)
- Suitable for EGFR-TKIs treatment and expectant duration over four weeks
- No specific therapies received within 4 weeks prior to enrollment which may induce similar skin reaction,such as Cetuximab, Sorafenib, Avastin.
- With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI-CTC\] grade ≥ 3)
- No other concomitant therapy referred to the face skin during the study
- Signed and dated informed consent
Exclusion
- Performance status ≥ 3(ECOG)
- Pregnant or breast-feeding patients
- The lesion counts can't be evaluated due to concomitant diseases or other conditions
- Not suitable for EGFR-TKIs treatment
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01528488
Start Date
December 1 2011
End Date
July 1 2013
Last Update
November 5 2013
Active Locations (1)
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1
Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060