Clinical Trials /

Hypofractionated Brain Radiation In EGFR Mutated Adenocarcinoma Cranial Disease (Hybrid)

NCT02882984

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/IcotinibEGFR-TKIWBRT along with 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

NameTypeDescriptionInterventions
WBRT along with TKIActive ComparatorDrug: 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 TKIExperimentalDrug: 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:Recruiting
Lead Sponsor:Sichuan Provincial People's Hospital

Last Updated

August 29, 2016