A Phase 3 interventional study of Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib and WBRT in Stage IV EGFR Mutated NSCL With Brain Metastases, sponsored by Sichuan Provincial People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-08-30.
Sponsored by Sichuan Provincial People's Hospital · Phase 3, Interventional, and Treatment
A multi-center phase III randomized controlled study to evaluate the efficacy of Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from non-small cell lung cancer (NSCLC). Assuming that HFSRS is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), evaluation of cognitive function, quality of life (QoL) and adverse events.
WBRT remains to be standard of care for NSCL patients. Long term survival from WBRT may have noticeable cognitive dysfunction. The EGFR TKI has reasonable control for intracranial disease, but the duration of EGFR TKI control disease is variable due to tendency of drug resistance. To maintain intracranial disease control and improve cognitive function, the investigators propose using hypofractionated SRS in multiple brain metastases or large brain lesions alone with TKI.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 325 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
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Drug: EGFR-TKI Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib Radiation: whole brain radiotherapy 3750Gy/15F Other Name: WBRT
Drug: Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib · Radiation: WBRT
Drug: EGFR-TKI Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib Radiation: whole brain radiotherapy 25 to 40 Gy/5F Other Name: HFSRS
Drug: Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib · Radiation: HFSRS
radiation given along with one of kind TKI
Also known as: EGFR-TKI
3750 cGy in 15 fractions given within 3 weeks time.
All HFSRS given in 5 fractions. dose per fraction ranges from 5 to 8 Gy depending on the target volume and organs at risk tolerance.
iPFS
intracranial progression-free survival
Time frame: 18 months
cognitive function
Neurocognitive effects evaluated according to Mini-Mental Status Examination Evaluated according to Mini-Mental Status Examination
Time frame: 18 month
Overall survival (OS)
Overall survival
Time frame: 18 months
Plan to share: Undecided
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Sichuan Provincial People's Hospital