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Nervous System Neoplasms

Brain Diseases

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Lapatinib

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Whole Brain Radiation Therapy (30Gy in 10 fractions) and lapatinib 1250mg once daily for 2 weeks followed by lapatinib treatment 1500mg once daily for 4 weeks.

Co-administration of lapatinib 1250mg once daily during the WBRT period (2 weeks)and then monotherapy with lapatinib 1500mg once daily for 4 weeks.

Christos Christodoulou, MD

This phase II open-label study will be performed to evaluate the response rate of brain metastases from lung and breast tumors under treatment with WBRT and lapatinib.

Patients with breast or lung cancer who have developed brain metastases will be treated with WBRT (30Gy in 10 fractions) and lapatinib 1250mg once daily, followed by lapatinib treatment 1500mg once daily for a total duration of 6 weeks. At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients. Subsequent to the 6 weeks treatment period with lapatinib, the patients may discontinue lapatinib as monotherapy and the physicians can proceed with any therapy, according to their discretion. The patients will be followed-up every 12 weeks for disease progression and survival.

Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors

Lapatinib and Whole Brain Radiotherapy for Patients With Brain Metastases From Lung and Breast Tumors. A Phase II Study of the Hellenic Cooperative Oncology Group (HeCOG).

Chest, abdomen, and pelvic Computerized Tomography (CT) scans will be performed at the 6 weeks timepoint to evaluate the response for systemic disease

Adverse Events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient.

Hellenic Cooperative Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors	NCT01218529	Brain Metastase... Lung Tumors Breast Tumors	Lapatinib	18 Years -	Hellenic Cooperative Oncology Group
Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors	NCT01218529	Brain Metastase... Lung Tumors Breast Tumors	Lapatinib	18 Years -	Hellenic Cooperative Oncology Group
Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors	NCT01218529	Brain Metastase... Lung Tumors Breast Tumors	Lapatinib	18 Years -	Hellenic Cooperative Oncology Group

Spots Global Cancer Trial Database for brain metastases from lung and breast tumors