Status:
TERMINATED
Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer
Lead Sponsor:
Oslo University Hospital
Conditions:
Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01518621
Start Date
May 1 2012
End Date
December 10 2018
Last Update
March 13 2019
Active Locations (1)
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1
The Norwegian Radium Hospital
Oslo, Norway, N-0310