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

NCT02714010 | Unknown Phase 3 DMC

• 1 other identifier: GASTO1014
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

EGFR-TKI; whole brain radiotherapy; brain metastasis; non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• intracranial PFS (iPFS)

  Compare intracranial PFS (iPFS) of two arms

  up to 41 months

Secondary Outcomes (2)

• overall survival (OS)

  up to 77 months

• objective response rate (ORR)

  up to 41 months

Other Outcomes (2)

• cognitive impairment

  up to 77 months

• quality of life (QoL)

  up to 77 months

Study Arms (2)

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

EGFR-TKI DRUG

Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid

Also known as: Gefitinib/Tarceva/Icotinib

Arm 1; Arm 2

whole brain radiotherapy RADIATION

30Gy/10F

Also known as: WBRT

Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University of cancer center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• li-kun Chen

  associate chief physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

li-kun Chen

CONTACT

13798019964; chenlk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Associate chief physician

Study Record Dates

• First Submitted: November 29, 2015
• First Posted: March 21, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

CN (1)