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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. WBRT alone | Experimental | 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 |
|
| 2. Erlotinib concurrent WBRT | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug |
| ||
| WBRT |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 3 years | |
| Complete response, Partial response, Stable disease, Progressive disease | 19 months | |
| Quality of Life |
| Measure | Description | Time Frame |
|---|---|---|
| The purpose of exploring |
| 3 years |
Inclusion Criteria:
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;
GPA score 0.5 - 3.5;
a week before randomization, bone marrow and liver and kidney function in patients with meet the following criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhenzhou-Yang | Chongqing | Chongqing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39830774 | Derived | 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. | |
| 33331923 |
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|
| 3 years |
| 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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