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Multiple Brain MetastasesPhase 3NCT01887795

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 study testing Erlotinib and WBRT in people with Multiple Brain Metastases and Non-small-cell Lung Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Erlotinib and WBRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteChina
Study dates
Aug 2013to Aug 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older;
  • the pathological diagnosis of non-small cell lung cancer and detection of pulmonary primary ARMs / sequencing EGFR mutation;
  • enhanced MRI showed brain metastases ≥ 2 or NSCLC of brain metastases after resection of residual lesions in ≥ 2 / intracranial metastases in patients with new;
  • if the previous use of EGFR-TKIs, in an WBRT synchronous Erotinib before treatment to disable EGFR-TKIs ≥ 4 weeks;
  • expected survival period over 2 months;
  • KPS score ≥ 70;
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  • GPA score 0.5 - 3.5;
  • a week before randomization, bone marrow and liver and kidney function in patients with meet the following criteria:
  • HB ≥ 100, g/L ≥ 1.5 × 109/L neutrophil and platelet ≥ 100 × 109/L;
  • 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;
  • more than 1.5 times the upper limit of normal serum creatinine or creatinine clearance rate ≥ 60 ml/min, urea N ≤ 200mg/L;
  • Urine dipstick testing the proteinuria < 1+; if the urine dipstick test value, 1+, is 24 hours total urine protein must < 500mg.
  • compliance research plan and follow-up process, and be able to carry out oral therapy;
  • 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;
  • can understand and consent.

Who cannot join

  • patients have been treated with radiation to the brain or to erlotinib and its ingredients allergies;
  • mixed with small cell lung cancer patients with components;
  • 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);
  • before entering the group 4 weeks received any other investigational drugs;
  • 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;
  • 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;
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  • on gastrointestinal physiology is not perfect, or absorb the obstacle syndrome, or unable to tolerate oral medication, or active peptic ulcer;
  • 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;
  • without full control of ocular inflammation or eye infections, or any may cause the eye disease situation;
  • known human immunodeficiency virus (HIV) infection;
  • with immunodeficiency disease, or suffer from other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
  • any disease, metabolic disorders, or physical examination or laboratory suspicion or treatment of complications in patients at high risk of drug.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhenzhou-Yang

    Chongqing, Chongqing Municipality

Other trials in China

About this study

  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.

Being tested
Erlotinib, WBRT
Keywords
Informed Consent;, Ethical Principles;, Data collection
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01887795
Study groupRoleWhat they receive
1. WBRT aloneExperimentalSelected 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
Receives: Drug: WBRT
2. Erlotinib concurrent WBRTExperimentalSelected 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
Receives: Drug: Erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to neurologic progression

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

    Measured: 13 months

Secondary outcomes (3)

  1. Overall Survival

    Measured: 3 years

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

    Measured: 19 months

  3. Quality of Life

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01887795
Sponsor's protocol ID
Yang-1970
Status last verified
Aug 2016
First submitted
8 Jun 2013
Last updated
25 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Tang F, Zhang J, Xu Z, Zhang Y, Zhang X, Peng Y, Yang Z. Health-related quality of life analysis from ENTER, a randomized, controlled phase III trial of whole-brain radiotherapy with and without concurrent erlotinib in NSCLC with brain metastases. Transl Lung Cancer Res. 2024 Dec 31;13(12):3289-3302. doi: 10.21037/tlcr-24-481. Epub 2024 Dec 27.

    PubMed 39830774

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erlotinib and WBRT in people with Multiple Brain Metastases and Non-small-cell Lung Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to neurologic progression (time frame: 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01887795, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.

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