Hypofractionated Brain Radiation In EGFR Mutated Adenocarcinoma Cranial Disease (Hybrid)
NCT ID: NCT02882984
Last Updated: 2016-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
325 participants
INTERVENTIONAL
2015-03-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
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
WBRT
3750 cGy in 15 fractions given within 3 weeks time.
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
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
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.
Interventions
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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
WBRT
3750 cGy in 15 fractions given within 3 weeks time.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Sichuan Provincial People's Hospital
OTHER
Responsible Party
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ming zeng, MD
Director of Cancer Center
Principal Investigators
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Ming Zeng, MD PhD
Role: STUDY_CHAIR
Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences
Locations
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Sichuan PPH, Cancer Center
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Hybrid
Identifier Type: -
Identifier Source: org_study_id
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