RT Plus EGFR-TKI for Wild-type NSCLC
NCT02738983 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2016-04-14
Summary
Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.
Conditions
- Non-small Cell Lung Cancer
- Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
Interventions
- DRUG
-
Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®)
Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day).
- RADIATION
-
Radiotherapy
Concurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week.
Sponsors & Collaborators
-
Hangzhou Cancer Hospital
lead OTHER
Principal Investigators
-
Shixiu Wu, MD · Hangzhou Cancer Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2016-12-31
- Completion
- 2017-12-31
Countries
- China
Study Locations
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