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

Martin-Luther-University (Germany)0 个研究点目标入组 80 人开始时间: 2005年7月5日最近更新: 2021年1月25日

适应症

试验速览

暂无简介。

•1. Women with histologically or cytologically confirmed, oligometastatic (stage IV) breast cancer, defined as: more than or equal to three metastatic lesions, or primary tumor and more than or equal to two metastatic lesions not amenable to curative surgery for medical or surgical reasons
•2. Estrogen- and progesterone receptor negative status, hormone-refractory or rapid progressive disease
•3. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (except patients with metastatic lesions confided to the bones who may be included in case of non-measurable, but assessasble disease
•4. Age 18 to 75 years, Performance Status (PS) zero to one
•5. Adequate renal, hematological and hepatic function
•6. Minimum estimated life expectancy three months
•7. Written informed consent
•8. Absence of any condition potentially hampering compliance with the study protocol and follow-up schedule

•1. Patients with cerebral metastasis as well as metastasis in anantomic proximity to peripherapy nerves precluding the delivery of the planned radiochemotherapy
•2. Malignant ascites, pericardial or pleural effusions
•3. Concomitant malignancy (except basal cell skin carcinoma and carcinoma in situ of the uterine cervix)
•4. Pregnant or lactating women, unclear contraception
•5. Prior radiation to the metastatic sites
•6. Prior treatment with taxanes
•7. Known hypersensitivity to taxanes or cremophor EL
•8. Patients with a history of grade III/IV peripheral neuropathy of any aetiology
•9. Patients with diabetes mellitus and a peripheral neuropathy of any etiology

发起方

Martin-Luther-University (Germany)