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

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518621
First Posted: January 26, 2012
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Odd Terje Brustugun, Oslo University Hospital
  Purpose
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.

Condition Intervention Phase
Cancer Radiation: Radiation Drug: Radiation plus erlotinib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Odd Terje Brustugun, Oslo University Hospital:

Enrollment: 25
Study Start Date: May 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiotherapy alone
Total brain irradiation, 3Gy x10
Radiation: Radiation
Whole brain radiation
Other Name: Whole brain radiation therapy
Experimental: Radiation plus erlotinib
Total brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation
Drug: Radiation plus erlotinib
Radiation 3Gy x10 plus erlotinib 150 mg q d, from the day before radiation start, through last day of irradiation
Other Name: Whole brain radiation therapy and tyrosin kinase inhibitor

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518621


Locations
Norway
The Norwegian Radium Hospital
Oslo, Norway, N-0310
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Odd Terje Brustugun, MD PhD Norwegian Radium Hospital
  More Information

Responsible Party: Odd Terje Brustugun, Senior consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01518621     History of Changes
Other Study ID Numbers: RadEr
First Submitted: January 19, 2012
First Posted: January 26, 2012
Last Update Posted: June 23, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action