NCT02338011

Comparator-Controlled Study for EGFR(+) Patients With Multiple BMs From NSCLC (BROKE) (EGFR-epidermal Growth Factor Receptor;BM-brain Metastases)

Gefitinib Alone or With Concomitant Whole Brain Radiotherapy for Patients Harboring an EGFR Mutation With Multiple Brain Metastases From Non-Small-cell Lung Cancer: a Phase II/III Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

1. Compare the effect and safety of gefitinib alone with gefitinib plus concomitant WBRT(whole-brain radiotherapy ) in treatment of NSCLC patients harboring an EGFR mutation with multiple BM. 2. Verify the failure pattern of NSCLC patients harboring an EGFR mutation with multiple BM. 3. Explore the rescuable therapy after progression of disease.

Detailed description

All patients will be randomized to receive gefitinib or gefitinib concurrent WBRT until progression of disease. Gefitinib concurrent WBRT, patients were given gefitinib 250mg per day concurrently with WBRT(whole-brain radiotherapy ). Dose reduction was allowed for intolerable adverse effects such as rash(grade 4)、diarrhea(grade 3-4) or non hematological toxicity(grade 3-4) from 250mg per day to 250mg every other day then to 250mg every three days if needed. WBRT was delivered in 3.0 Gy(Gray)fractions once per day 5 days per week to a total dose of 30Gy (10 fractions). Radiation was delivered as opposed lateral 6-MV(Micro Voltage) beams with Varian linear accelerator.

Conditions

• Non-Small Cell Lung Cancer
• Brain Metastases
• EGFR Gene Mutation

Interventions

Type	Name	Description
DRUG	Gefitinib	Gefitinib was given 250mg per day. Dose reduction was allowed for intolerable adverse effects such as rash(grade 4)、diarrhea(grade 3-4) or non hematological toxicity(grade 3-4) from 250mg per day to 250mg every other day then to 250mg every three days if needed.
RADIATION	WBRT	WBRT was delivered in 3.0 Gy fractions once per day 5 days per week to a total dose of 30Gy (10 fractions).

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2015-01-14
• Last updated: 2015-01-26

Locations

1 site across 1 country: China