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Brief Title: Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors
Official Title: 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).
Study ID: NCT01218529
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
General Hospital of Athens 'Hippokratio', 2nd Dept of Internal Medicine, Athens, , Greece
Sotiria General Hospital, 3rd Dept of Medicine, Oncology Unit, Athens, , Greece
General Peripheral Hospital of Athens "Alexandra", Athens, , Greece
Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology, Athens, , Greece
Hygeia Hospital, 1st Dept of Medical Oncology, Athens, , Greece
Hygeia Hospital, 2nd Dept of Medical Oncology, Athens, , Greece
Metropolitan Hospital, 1st Dept of Medical Oncology, Athens, , Greece
Metropolitan Hospital, 2nd Dept of Medical Oncology, Athens, , Greece
Chania General Hospital, Oncology Section, Chania, , Greece
Ioannina University Hospital, Dept of Medical Oncology, Ioannina, , Greece
University Hospital of Larissa, Dept of Internal Medicine, Oncology Section, Larissa, , Greece
Rio University Hospital, Dept of Medical Oncology, Patras, , Greece
Papageorgiou General Hospital, Dept of Medical Oncology, Thessaloniki, , Greece
Name: Christos Christodoulou, MD
Affiliation: Metropolitan Hospital, 2nd Dept of Medical Oncology
Role: STUDY_CHAIR