EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis... | NCT02714010

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

NCT02714010

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Oct 27, 2017Actual

Enrollment

601Estimated

Phase

Phase 3

Conditions

Non-Small Cell Lung Cancer

Interventions

EGFR-TKI
whole brain radiotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Nov 29, 2015

First Submission Date that Met QC Criteria

Mar 15, 2016

First Posted Date

Mar 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2017

Last Update Posted Date

Oct 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

601Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Patients take EGFR-TKI alone till tumor progression	Drug: EGFR-TKI
Arm 2	Active Comparator	Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI	Drug: EGFR-TKI Radiation: whole brain radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EGFR-TKI	Drug	Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid	Arm 1 Arm 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intracranial PFS (iPFS)	Compare intracranial PFS (iPFS) of two arms	up to 41 months

Secondary Outcomes

Measure	Description	Time Frame
overall survival (OS)		up to 77 months
objective response rate (ORR)		up to 41 months

Other Outcomes

Measure	Description	Time Frame
cognitive impairment	questionnaire	up to 77 months
quality of life (QoL)	questionnaire	up to 77 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D001932	Brain Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds