EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Whole Brain Radiotherapy Concurrent With EGFR-TKI Versus EGFR-TKI Alone in the Treatment of Non-small Cell Lung Cancer Patients With Brain Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02714010
• Other study ID #: GASTO1014
• Status: Recruiting
• Phase: Phase 3
• First received: November 29, 2015
• Last updated: October 25, 2017
• Start date: August 2015
• Est. completion date: December 2022

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: li-kun Chen
• Phone: 13798019964
• Email: chenlk[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 601
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).

• Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery(SRS).

• Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm in brain (by brain MRI).

• Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group(ECOG) performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin > 10g/dl, absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L; total bilirubin < 1.5x upper limit of normal (ULN). Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)< 1.5x ULN in the absence of liver metastases, or < 5x ULN in case of liver metastases. Creatinine clearance > 60ml/min (calculated according to Cockcroft-gault formula).

• Patients should be contraceptive during the period of the trial.

Exclusion Criteria:

• Patients who had received brain radiotherapy or EGFR-TKI before.

• Patients who can't receive WBRT.

• Uncontrolled intracranial hypertension after steroid or dehydration therapy.

• Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wort which will interfere with the metabolism of TKI.

• Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.

• Patients who can't take oral tablets, with active peptic ulcer diseases.

• Pregnancy or breast-feeding women.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non-Small Cell Lung Cancer

Intervention

Drug:
• EGFR-TKI
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid

Radiation:
• whole brain radiotherapy
30Gy/10F

Locations

Country	Name	City	State
China	Sun Yat-sen University of cancer center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cognitive impairment	questionnaire	up to 77 months
Other	quality of life (QoL)	questionnaire	up to 77 months
Primary	intracranial PFS (iPFS)	Compare intracranial PFS (iPFS) of two arms	up to 41 months
Secondary	overall survival (OS)		up to 77 months
Secondary	objective response rate (ORR)		up to 41 months