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Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Brain Metastases, Radiation Therapy

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Trial Information


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


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

Type of Study:

Interventional

Study Design:

N/A

Authority:

Norway: Norwegian Medicines Agency

Study ID:

RadEr

NCT ID:

NCT01518621

Start Date:

Completion Date:

Related Keywords:

  • Lung Cancer, Brain Metastases, Radiation Therapy
  • Brain Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis

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