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Phase 3
18 Years
Not Enrolling
Multiple Brain Metastases, Non-small-cell Lung Cancer

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Trial Information

All patients will be randomized to receive WBRT or Erlotinib concurrent WBRT. Erlotinib
concurrent WBRT, patients were given a loading dose of erlotinib 150mg per day for 6 days,
after which all patients received erlotinib 150mg per day concurrently with WBRT. Dose
reduction was allowed for intolerable adverse effects (grade ≥3) such as rash or diarrhea in
50 mg increments down from 150mg to 100 mg and then to 50 mg if needed. Radiation therapy
was delivered in 2.0 Gy fractions once per day 5 days per week to a total dose of 40Gy (20
fractions). Radiation was delivered as opposed lateral 8-MV beams with a Sweden precise
linear accelerator.

Inclusion Criteria:

1. Pathological diagnosis in patients with non-small cell lung cancer

2. Patients ≥ 18 years of age;

3. pathological diagnosis of non-small cell lung cancer and lung primary tumor for EGFR
mutation detection method ARMs;

4. enhanced MRI showed brain metastases ≥ 2 or resection of brain metastases from NSCLC
presence of residual lesions ≥ 2 / intracranial metastases in patients with

5. Accept WBRT concurrent disabled erlotinib treatment Iressa ≥ 14 days;

6. Expected survival ≥ 3 months;

7. KPS score ≥ 70;

8. GPA score 0.5-4;

9. week before randomization, patients with bone marrow and liver and kidney function
meet the following criteria:

① hemoglobin ≥ 10 g / L, neutrophils ≥ 1.5 × 109 / L and platelets ≥ 10 × 109 / L;

② total bilirubin ≤ 1.0 times upper limit of normal, aspartate aminotransferase (AST)
and alanine aminotransferase (ALT) ≤ 1.5 times upper limit of normal;

③ creatinine ≤ 15mg / L, urea nitrogen ≤ 200mg / L;

10. able to understand and sign the informed consent.-

Exclusion Criteria:

1. patient had received brain radiotherapy;

2. there is a significant uncontrolled diseases such as AIDS, neurological / mental
illness such as Alzheimer's disease;

3. pregnant or lactating women; fertile without taking adequate contraceptive measures

4.4 weeks before enrollment received any other investigational drug;

5.There is a history of immune deficiency, or suffering from other acquired, congenital
immunodeficiency disease, or history of organ transplantation;

6.According to the researchers judged serious harm or affect patient safety comorbidity in
patients who completed the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to neurologic progression

Outcome Description:

A) assess the local control of brain metastases status (including: the proportion of salvage therapy, the proportion of radiation necrosis lesions) B) evaluation of intracranial metastasis status (at the site of the primary tumor than the emergence of new brain metastases)

Outcome Time Frame:

13 months

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

August 2013

Completion Date:

August 2016

Related Keywords:

  • Multiple Brain Metastases
  • Non-Small-Cell Lung Cancer
  • Informed Consent;
  • Ethical Principles;
  • Data collection
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms