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Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01951482
Recruitment Status : Unknown
Verified October 2017 by Li-kun Chen, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : September 26, 2013
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Li-kun Chen, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE September 16, 2013
First Posted Date  ICMJE September 26, 2013
Last Update Posted Date October 26, 2017
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
Compare iPFS(intracranial progression free survival) in two arms [ Time Frame: 3 Years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
Response rate(CR&PR) [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 23, 2013)
  • PFS: progress free survival [ Time Frame: 3 years ]
  • OS: overall survival [ Time Frame: 3 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer
Official Title  ICMJE Multicenter Phase II Study of Pemetrexed/Cisplatin With or Without Bevacizumab in Patients With Brain Metastases From Non Squamous Non-small Cell Lung Cancer Harboring EGFR Wild Type
Brief Summary This is a multi-center phase II randomized controlled study to assess the efficacy of Pemetrexed/cisplatin with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR wild type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Squamous Non-small Cell Lung Cancer
  • Brain Metastases
  • Bevacizumab
Intervention  ICMJE
  • Drug: Pemetrexed/cisplatin
    receive Pemetrexed/cisplatin every 21 days
  • Drug: Bevacizumab and Pemetrexed/cisplatin
    receive Bevacizumab 7.5mg/kg and Pemetrexed/cisplatin every 21 days
Study Arms  ICMJE
  • Experimental: Bevacizumab and Pemetrexed/cisplatin
    Bevacizumab 7.5mg/kg d1+Pemetrexed/cisplatin q21d
    Intervention: Drug: Bevacizumab and Pemetrexed/cisplatin
  • Active Comparator: Pemetrexed/cisplatin
    Pemetrexed/cisplatin q21d
    Intervention: Drug: Pemetrexed/cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 23, 2013)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brain metastases by pathologic histology or cytology
  2. Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases
  3. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI
  4. Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
  5. Patients should be contraceptive during the period of the trial

Exclusion Criteria:

  1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
  2. History of haemoptysis
  3. Evidence of tumour invading major blood vessels on imaging.
  4. Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
  5. Previous radiotherapy.
  6. Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6 months prior to study start or history of serious bleeding complications.
  7. Major surgical procedures within 4 weeks prior to study entry.
  8. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
  9. Non-healing wound, active peptic ulcer or bone fracture.
  10. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01951482
Other Study ID Numbers  ICMJE NSCLC brain metastasis 02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Li-kun Chen, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: li-kun Chen, Doctor Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP