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

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ClinicalTrials.gov Identifier: NCT02882984
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
ming zeng, MD, Sichuan Provincial People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage IV EGFR Mutated NSCL With Brain Metastases Drug: Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib Radiation: WBRT Radiation: HFSRS Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparing Whole Brain Radiation With Hypofractionated Stereotactic RadioSurgery (HFSRS) in Patients With NSCL Brain Metastases
Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: WBRT along with TKI

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 given along with one of kind TKI
Other Name: EGFR-TKI

Radiation: WBRT
3750 cGy in 15 fractions given within 3 weeks time.

Experimental: HFSRS with EGFR TKI

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 given along with one of kind TKI
Other Name: EGFR-TKI

Radiation: HFSRS
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.




Primary Outcome Measures :
  1. iPFS [ Time Frame: 18 months ]
    intracranial progression-free survival


Secondary Outcome Measures :
  1. cognitive function [ Time Frame: 18 month ]
    Neurocognitive effects evaluated according to Mini-Mental Status Examination Evaluated according to Mini-Mental Status Examination

  2. Overall survival (OS) [ Time Frame: 18 months ]
    Overall survival



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882984


Contacts
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Contact: YiFeng Bai, MD PhD 008618183298718 15756285949@qq.com
Contact: ming zeng, MD PhD 17708131336 miller2002@yahoo.com

Locations
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China, Sichuan
Sichuan PPH, Cancer Center Recruiting
Chengdu, Sichuan, China, 710062
Contact: Yifeng Bai, MD PhD    18183298718    15756285949@qq.com   
Contact: Ming zeng, MD PhD    008617708131336    miller2002@yahoo.com   
Sponsors and Collaborators
Sichuan Provincial People's Hospital
Investigators
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Study Chair: Ming Zeng, MD PhD Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences

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Responsible Party: ming zeng, MD, Director of Cancer Center, Sichuan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02882984    
Other Study ID Numbers: Hybrid
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Gefitinib
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action