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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01518621
First received: January 19, 2012
Last updated: January 25, 2012
Last verified: January 2012
  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
Lung Cancer, Brain Metastases, Radiation Therapy
Radiation: Radiation
Drug: Radiation plus erlotinib
Phase 2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Arms Assigned Interventions
Active Comparator: Radiotherapy alone
Total brain irradiation, 3Gy x10
Radiation: Radiation
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518621

Contacts
Contact: Odd Terje Brustugun, MD PhD 22934000 ext +47 otr@ous-hf.no
Contact: Åslaug Helland, MD PhD 22934000 ext +47 ahh@ous-hf.no

Locations
Norway
The Norwegian Radium Hospital Recruiting
Oslo, Norway, N-0310
Contact: Brustugun    22934000 ext +47      
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01518621     History of Changes
Other Study ID Numbers: RadEr
Study First Received: January 19, 2012
Last Updated: January 25, 2012
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Brain Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Brain Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Central Nervous System Diseases
Central Nervous System Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Nervous System Neoplasms
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014