Integration of 3D-conformal, local radiotherapy (3DCRT) to metastatic sites in a paclitaxel weekly chemotherapy regimen in oligometastatic breast cancer patients: a phase I- and randomised phase II-study - Paclitaxel-3DCRT

Martin-Luther-University0 个研究点目标入组 100 人开始时间: 2005年12月22日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- women with histologically or cytologically confirmed, oligometastatic breast cancer (stage IV), defined as either - ER- and progesterone receptor (PgR)-negative status, hormone-refractory or rapid progressive disease. HER-2 positive patients are allowed only in the phase II-part of the study
•- failure of prior anthracycline therapy (unless contra-indicated)
•- adequate hematological, renal and liver function
•- age 18-75 years, ECOG performance status 0-1
•- effective contraception
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•- patients with cerebral metastases, as well as metastases in anatomic proximity to peripheral nerves procluding the delivery of the planned radiochemotherapy
•- malignant ascites, pericardial or pleural effusions
•- uncontrolled concommitant malignancy
•- pregnant or lactating women
•- prior radiation to the metastatic sites
•- prior treatment with taxanes
•- known hypersensitivity to taxanes or Cremophor EL
•- patients with a history of grade III/IV peripheral neuropathy of any etiology
•- patients with diabetes mellitus and a peripheral neuropathy > grade I

发起方

Martin-Luther-University