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CompletedNCT01887795Updated Aug 25, 2016

Phase Ⅲ Trial of WBRT Versus Erlotinib Concurrent Whole-brain Radiation Therapy as first-line Treatment for Patients With Multiple Brain Metastases From Non-small-cell Lung Cancer(ENTER): a Multicentre, Open-label, Randomised Study

A Phase 3 interventional study of Erlotinib and WBRT in Multiple Brain Metastases and Non-small-cell Lung Cancer, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-25.

Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the detailed 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.

02

Conditions studied

  • Multiple Brain Metastases
  • Non-small-cell Lung Cancer

Keywords

  • Informed Consent;
  • Ethical Principles;
  • Data collection
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 224 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 115 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
224 participants (actual)

Study arms

  • Experimental
    1. WBRT alone

    Selected 224 patients with multiple brain metastases from NSCLC, they will be randomized to WBRT or Erotinib concurrent WBRT. It was enough to compare the efficacy of Erotinib concurrent WBRT vs. WBRT

    Drug: WBRT

  • Experimental
    2. Erlotinib concurrent WBRT

    Selected 224 patients with multiple brain metastases from NSCLC, they will be randomized to WBRT or Erotinib concurrent WBRT. It was enough to compare the efficacy of Erotinib concurrent WBRT vs. WBRT

    Drug: Erlotinib

Interventions

  • DrugErlotinib
  • DrugWBRT
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 13 months

Secondary outcomes

  1. Overall Survival

    Time frame: 3 years

  2. Complete response, Partial response, Stable disease, Progressive disease

    Time frame: 19 months

  3. Quality of Life

    Time frame: 3 years

Other outcomes

  1. The purpose of exploring

    1. Focal EGFR 1 certification pre built NSCLC mutation prediction model of brain metastasis. 2. Blood sample was collected for patients with Erotinib biomarker research.

    Time frame: 3 years

07

Study locations

1 site
  • Zhenzhou-Yang
    Chongqing, Chongqing, China
08

References and documents

Publications

  • Yang Z, Zhang Y, Li R, Yisikandaer A, Ren B, Sun J, Li J, Chen L, Zhao R, Zhang J, Xia X, Liao Z, Carbone DP. Whole-brain radiotherapy with and without concurrent erlotinib in NSCLC with brain metastases: a multicenter, open-label, randomized, controlled phase III trial. Neuro Oncol. 2021 Jun 1;23(6):967-978. doi: 10.1093/neuonc/noaa281. PubMed 33331923 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01887795
Lead sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Responsible party
Zhen-zhou Yang (Director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University) — Principal investigator
First posted
Jun 27, 2013
Start date
Aug 2013
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Aug 25, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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