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

Primary Purpose

Non-Small Cell Lung Carcinoma

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IMRT
WBRT
erlotinib
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Carcinoma focused on measuring Non-Small Cell Lung Cancer, IMRT, erlotinib, whole-brain radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically confirmed NSCLC and wild type EGFR
  • 4-10 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Hui Liu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IMRT & erlotinib

whole-brain radiotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

CNS progression free survival

Secondary Outcome Measures

Full Information

First Posted
September 19, 2015
Last Updated
April 10, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02556593
Brief Title
IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
Official Title
IMRT Combined With Erlotinib Compared With Whole-brain Radiotherapy for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. All patients recruited will be randomly assigned into two groups. Patients in experimental group will receive daily IMRT at 45 Gy in 15 fractions to brain metastases, combined with daily erlotinib of 150mg for three weeks. Patients in control group will receive daily whole-brain radiotherapy at 30 Gy in 10 fractions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Carcinoma
Keywords
Non-Small Cell Lung Cancer, IMRT, erlotinib, whole-brain radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMRT & erlotinib
Arm Type
Experimental
Arm Description
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
Arm Title
whole-brain radiotherapy
Arm Type
Active Comparator
Arm Description
Patients in this group receive WBRT at 30Gy in 10 fractions
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
Daily IMRT at 45 Gy in 15 fractions to brain metastases
Intervention Type
Radiation
Intervention Name(s)
WBRT
Intervention Description
3DCRT at 30 Gy in 10 fractions to whole brain
Intervention Type
Drug
Intervention Name(s)
erlotinib
Intervention Description
erlotinib 150mg daily
Primary Outcome Measure Information:
Title
CNS progression free survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed NSCLC and wild type EGFR 4-10 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, professor
Organizational Affiliation
Sun yat-sen universtiy cancer center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hui Liu
City
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

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

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