IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases

NCT02556593 | Terminated Phase 2

• 1 other identifier: GASTO1009
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.

Conditions

Non-Small Cell Lung Carcinoma

Keywords

Non-Small Cell Lung Cancer; IMRT; erlotinib; whole-brain radiotherapy

Outcome Measures

Primary Outcomes (1)

• CNS progression free survival

  2 years

Study Arms (2)

IMRT & erlotinib

EXPERIMENTAL

Patients in experimental group receive IMRT and erlotinib: Daily IMRT(45Gy in 15 fractions) to the brain metastases with daily erlotinib(150mg.po) for three weeks

Radiation: IMRT; Drug: erlotinib

whole-brain radiotherapy

ACTIVE COMPARATOR

Patients in this group receive WBRT at 30Gy in 10 fractions

Radiation: WBRT

Interventions

IMRT RADIATION

Daily IMRT at 45 Gy in 15 fractions to brain metastases

IMRT & erlotinib

WBRT RADIATION

3DCRT at 30 Gy in 10 fractions to whole brain

whole-brain radiotherapy

erlotinib DRUG

erlotinib 150mg daily

IMRT & erlotinib

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed NSCLC and wild type EGFR
• brain metastases on high quality CT scanning or MRI.
• No previous EGFR-TKI treatment.
• No previous brain radiotherapy.
• More than 4 weeks from last chemotherapy.
• Expected Survival of at least 2 months.
• KPS≥ 70
• RTOG RPA performance status 0-1
• Lab tests should meet these criteria: White blood cell count ≥3×10\^9 /L;Platelet count≥100×10\^9 /L;Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; Serum creatinine 1.5 times or less the ULN or creatinine clearance rate(CCR) greater than or equal to 60 ml/min.
• Pregnancy test (-)
• Be able to sign informed consent form.

You may not qualify if:

• With unstable systematical diseases (concluding acute infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, hepatopathy, nephropathy, metabolic diseases)
• With metastases on meninges.
• Taking antiepileptics (phenytoin sodium etc.) at the same time
• Unable to oral medication.
• Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Hui Liu

Guangdong, 510000, China

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hui Liu, professor

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2015
• First Posted: September 22, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

CN (1)