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
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.
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 →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.
a week before randomization, bone marrow and liver and kidney function in patients with meet the following criteria:
Exclusion Criteria:
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
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
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
Overall Survival
Time frame: 3 years
Complete response, Partial response, Stable disease, Progressive disease
Time frame: 19 months
Quality of Life
Time frame: 3 years
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
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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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University