Description:
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.
Title
- Brief Title: Hypofractionated Brain Radiation In EGFR Mutated Adenocarcinoma Cranial Disease (Hybrid)
- Official Title: Comparing Whole Brain Radiation With Hypofractionated Stereotactic RadioSurgery (HFSRS) in Patients With NSCL Brain Metastases
Clinical Trial IDs
- ORG STUDY ID:
Hybrid
- NCT ID:
NCT02882984
Conditions
- Stage IV EGFR Mutated NSCL With Brain Metastases
Interventions
Drug | Synonyms | Arms |
---|
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib | EGFR-TKI | HFSRS with EGFR TKI |
Purpose
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.
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
WBRT along with TKI | Active Comparator | 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 | - Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib
|
HFSRS with EGFR TKI | Experimental | 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 | - Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib
|
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological confirmation of non-small cell lung cancer (NSCLC);
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI.
- More than 3 sites of intracranial metastases, or the longest diameter of the
intracranial lesion is more than 4 cm.
- Positive EGFR mutation.
- Life expectancy ≥3months.
- Have one or more measurable encephalic lesions according to RECIST.
- Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and
Platelet count ≥100 x 109/L.
- Adequate renal function: Serum creatinine ≤1.5 x ULN, or ≥ 50 ml/min.
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and
Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN in the
absence of liver metastases, or < 5 x ULN in case of liver metastases.
- Female subjects should not be pregnant.
- All human subjects should able to comply with the required protocol and follow-up
procedures, and able to receive oral medications.
- Written informed consent provided.
Exclusion Criteria:
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin,
erbitux.
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
- Allergic to Icotinib.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption
syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Pregnancy or breast-feeding women.
- Participate in the other anti-tumor clinical trials in 4 weeks.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | iPFS |
Time Frame: | 18 months |
Safety Issue: | |
Description: | intracranial progression-free survival |
Secondary Outcome Measures
Measure: | cognitive function |
Time Frame: | 18 month |
Safety Issue: | |
Description: | Neurocognitive effects evaluated according to Mini-Mental Status Examination Evaluated according to Mini-Mental Status Examination |
Measure: | Overall survival (OS) |
Time Frame: | 18 months |
Safety Issue: | |
Description: | Overall survival |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Sichuan Provincial People's Hospital |
Last Updated
August 30, 2016