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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01887795
Other study ID # Yang-1970
Secondary ID
Status Completed
Phase Phase 3
First received June 8, 2013
Last updated August 24, 2016
Start date August 2013
Est. completion date August 2016

Study information

Verified date August 2016
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

1. Verify the effect of Erlotinib concurrent whole-brain radiation therapy as first-line treatment for patients with multiple brain metastases from non-small-cell lung cancer to compare with WBRT alone.

2. Verify pre-built EGFR mutation prediction model for NSCLC brain metastases


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. 18 years of age or older;

2. the pathological diagnosis of non-small cell lung cancer and detection of pulmonary primary ARMs / sequencing EGFR mutation;

3. enhanced MRI showed brain metastases = 2 or NSCLC of brain metastases after resection of residual lesions in = 2 / intracranial metastases in patients with new;

4. if the previous use of EGFR-TKIs, in an WBRT synchronous Erotinib before treatment to disable EGFR-TKIs = 4 weeks;

5. expected survival period over 2 months;

6. KPS score = 70;

7. GPA score 0.5 - 3.5;

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

1. HB = 100, g/L = 1.5 × 109/L neutrophil and platelet = 100 × 109/L;

2. total bilirubin = 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 1.5 times the upper limit of normal;

3. more than 1.5 times the upper limit of normal serum creatinine or creatinine clearance rate = 60 ml/min, urea N = 200mg/L;

4. Urine dipstick testing the proteinuria < 1+; if the urine dipstick test value, 1+, is 24 hours total urine protein must < 500mg.

9. compliance research plan and follow-up process, and be able to carry out oral therapy;

10. in women of childbearing age, must be in before starting treatment within 7 day of urine pregnancy test and the result is negative, and not in the lactation period, and reproductive age men and women prior to entry into the study, the research process until 90 days after stopping all agree to use reliable methods of contraception;

11. can understand and consent.

Exclusion Criteria:

1. patients have been treated with radiation to the brain or to erlotinib and its ingredients allergies;

2. mixed with small cell lung cancer patients with components;

3. 5 years before other cancers except NSCLC treatment in patients with the start of the study (except for simple operation resection and there are at least 5 consecutive years disease free survival, has been cured of cervical carcinoma in situ, has cured the base cell cancer and bladder epithelial tumor);

4. before entering the group 4 weeks received any other investigational drugs;

5. judgment according to the researchers, there are serious harm to patient safety or affect the patients completed the study with the disease, and patient compliance with the difference;

6. had any clinical evidence of moderate to severe chronic obstructive pulmonary disease (COPD -COPD a history or risk factors of pulmonary function testing, FEV1/FVC<70%, FEV1<80% estimates, with or without chronic cough, sputum, difficulty breathing), activity of interstitial lung disease (-ILD pulmonary function test FEV1/FVC<70%, FEV1<80% estimates, dispersion carbon monoxide lung volume -DLCO<40%, high resolution CT showed a diffuse interstitial lung disease) disease activity and other researchers decided;

7. on gastrointestinal physiology is not perfect, or absorb the obstacle syndrome, or unable to tolerate oral medication, or active peptic ulcer;

8. any unstable system diseases: including active infection, uncontrolled hypertension, unstable angina pectoris, within the last 3 months of the onset of angina, congestive heart failure, the group in June before the myocardial infarction, need serious mental disorder drug treatment, liver, kidney or metabolic diseases; mental / spiritual diseases such as Alzheimer's disease;

9. without full control of ocular inflammation or eye infections, or any may cause the eye disease situation;

10. known human immunodeficiency virus (HIV) infection;

11. with immunodeficiency disease, or suffer from other acquired, congenital immunodeficiency disease, or a history of organ transplantation;

12. any disease, metabolic disorders, or physical examination or laboratory suspicion or treatment of complications in patients at high risk of drug.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Erlotinib

WBRT


Locations

Country Name City State
China Zhenzhou-Yang Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other The purpose of exploring Focal EGFR 1 certification pre built NSCLC mutation prediction model of brain metastasis.
Blood sample was collected for patients with Erotinib biomarker research.
3 years No
Primary Time to neurologic progression 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)
13 months Yes
Secondary Overall Survival 3 years Yes
Secondary Complete response, Partial response, Stable disease, Progressive disease 19 months Yes
Secondary Quality of Life 3 years Yes
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