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Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer (RadEr)

Primary Purpose

Cancer

Status
Terminated
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Radiation
Radiation plus erlotinib
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

  • Newly diagnosed multiple brain metastases not suitable for first-line chemotherapy
  • Relapsed NSCLC with newly diagnosed multiple brain metastases

  • Relapsed NSCLC after second-line or more chemotherapy regimens with newly diagnosed multiple brain metastases

    • Diagnosis of brain metastases confirmed by MRI (or CT if MRI is not available/possible) within the past 4 weeks
    • Symptoms attributable to brain metastases
    • Patients who have undergone craniotomy with incomplete resection are eligible
    • Clinician's opinion that whole-brain radiotherapy (WBRT) will be beneficial
    • ECOG PS 0-2
    • Age above 18 years
    • Serum bilirubin < 2 times upper limit of normal (ULN)
    • AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)
    • Creatinine < 1.5 times ULN
    • Able to take oral medication
    • Not pregnant or nursing
    • Negative pregnancy test
    • Fertile patients must use effective contraception
    • No other prior or concurrent malignant disease likely to interfere with study treatment or comparisons

Exclusion Criteria:

  • More than 3 sites (organ systems) of extracranial metastases
  • Evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy
  • Evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications

Sites / Locations

  • The Norwegian Radium Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiotherapy alone

Radiation plus erlotinib

Arm Description

Total brain irradiation, 3Gy x10

Total brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 19, 2012
Last Updated
March 12, 2019
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01518621
Brief Title
Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer
Acronym
RadEr
Official Title
Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 10, 2017 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine if erlotinib given orally along with concurrent whole brain irradiation in lung cancer patients with brain metastases improves median overall survival and enhances local control compared to those treated with WBRT alone, without significantly increasing the risk of side effects or lowering quality of life.
Detailed Description
Endpoints Primary: • To determine if erlotinib given orally along with concurrent WBRT in lung cancer patients with brain metastases, improves median overall survival compared to those treated with WBRT alone. Secondary: To confirm the safety profile of erlotinib along with concurrent WBRT, in the context of treating central nervous system malignancies. To evaluate if erlotinib along with concurrent WBRT increases local control rate as measured by MRI at 8 weeks, compared to WBRT alone. To evaluate if erlotinib along with concurrent WBRT increases time to neurologic progression of disease based on neuropsychological assessment at baseline, at 8 and 20 weeks after WBRT. To evaluate quality of life parameters in patients treated with WBRT alone vs concomitant erlotinib and WBRT To evaluate if mutation status has impact on the above mentioned parameters Trial design Open multicenter randomized phase II trial. Patients Patients > 18 years with histologically confirmed NSCLC and brain metastases verified on either CT or MRI, not eligible for neurosurgery or stereotactic radiation therapy. Trial treatment Patients will be randomized 1:1 to either treatment arm A or B. Arm A: WBRT 3 Gy x10 alone. Arm B: WBRT 3 Gy x10 and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation. Number of patients 150 patients will be included, 75 in each arm

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy alone
Arm Type
Active Comparator
Arm Description
Total brain irradiation, 3Gy x10
Arm Title
Radiation plus erlotinib
Arm Type
Experimental
Arm Description
Total brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation
Intervention Type
Radiation
Intervention Name(s)
Radiation
Other Intervention Name(s)
Whole brain radiation therapy
Intervention Description
Whole brain radiation
Intervention Type
Drug
Intervention Name(s)
Radiation plus erlotinib
Other Intervention Name(s)
Whole brain radiation therapy and tyrosin kinase inhibitor
Intervention Description
Radiation 3Gy x10 plus erlotinib 150 mg q d, from the day before radiation start, through last day of irradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: Newly diagnosed multiple brain metastases not suitable for first-line chemotherapy Relapsed NSCLC with newly diagnosed multiple brain metastases Relapsed NSCLC after second-line or more chemotherapy regimens with newly diagnosed multiple brain metastases Diagnosis of brain metastases confirmed by MRI (or CT if MRI is not available/possible) within the past 4 weeks Symptoms attributable to brain metastases Patients who have undergone craniotomy with incomplete resection are eligible Clinician's opinion that whole-brain radiotherapy (WBRT) will be beneficial ECOG PS 0-2 Age above 18 years Serum bilirubin < 2 times upper limit of normal (ULN) AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present) Creatinine < 1.5 times ULN Able to take oral medication Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior or concurrent malignant disease likely to interfere with study treatment or comparisons Exclusion Criteria: More than 3 sites (organ systems) of extracranial metastases Evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy Evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odd Terje Brustugun, MD PhD
Organizational Affiliation
Norwegian Radium Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway

12. IPD Sharing Statement

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Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer

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