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A Randomized, Double-blind, Prospective Trial of Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in Non-small Cell Lung Cancer


Phase 2/Phase 3
N/A
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

A Randomized, Double-blind, Prospective Trial of Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in Non-small Cell Lung Cancer


Not suitable: no more information is needed to be described.


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Lesion counts in total face at completion of the study period (week 4)

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

li zhang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

EVOZAC20110210

NCT ID:

NCT01528488

Start Date:

December 2011

Completion Date:

March 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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