NL-OMON34632已完成2 期
A Randomized Phase II Study Of Reirradiation And Hyperthermia Versus Reirradiation And Hyperthermia Plus Chemotherapy For Locally Recurrent Breast Cancer In Previously Irradiated Area - ReHypCi
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Macroscopic local regional recurrence of breast cancer in previously irradiated area, not suitable for resection
- •* recurrence is measurable by clinical examination and/or radiological (CT-scan, MRI or ultrasound) assessment
- •* Confirmation of diagnosis of the local regional recurrence including all subtypes of invasive adenocarcinoma by histology or FNA (fine needle aspiration)
- •* Local regional recurrence of breast cancer must be treatable with radiation and hyperthermia at the discretion of the treating physician (i.e. thickness * 4 cm; cross-sectional diameter * 30 cm).
- •* Digital photograph of recurrence
- •* WBC * 3,000, NG* 1,000, platelets * 100,000, ANC * 1500
- •* serum bilirubin * 1.5 times upper limit of normal, transaminase * 3 times upper limit of normal
- •* calculated creatinine clearance > 60 ml/liter (Cockroft)
- •* distant metastases are allowed if life expectancy is * 1 year i.e. limited bone metastases
- •* Concurrent endocrine/hormonal therapy is allowed
- •* ECOG performance score * 2
- •* Written informed consent
- •* Patients must be older than 18 year
- •* Patient must not be pregnant or lactating. If appropriate effective contraception must be used.
排除标准
- •* Concurrent chemotherapy other than study medication
- •* Uncontrolled infection
- •* Other previous malignancy that could conceivably be active.
- •* Patients with pacemakers or implanted defibrillators on the same site as the treatment (if this is the case, the pacemaker or implanted defibrillator should be replaced if possible)
研究者
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