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
- Conditions
- oligometastatic breast cancer
- Registration Number
- EUCTR2005-003327-39-DE
- Lead Sponsor
- Martin-Luther-University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 100
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method