All patients with a local regional recurrence of invasive breast cancer in previously irradiated area with measurable lesions not suitable for resection are eligible for this trial. Patients with metastases are allowed if their life expectancy is considered 1 year or more, i.e. a limited bone metastases. MedDRA version: 12.1 Level: LLT Classification code 10008456 Term: Chemotherapy single agent systemic
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: CISPLATIN
CAS Number: 15663271
Other descriptive name: Cisplatinum
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentratio
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore if there is an indication of a positive effect on local control rate of adding Cisplatin to local reirradiation and hyperthermia to patients with local regional recurrent breast cancer in previously irradiated area ;Secondary Objective: - To describe the effect of adding Cisplatin to the standard treatment on acute toxicity - To describe the effect of adding Cisplatin to the standard treatment on clinical complete response rate - To explore the effect of adding Cisplatin to the standard treatment on time to disease progression local, regional or distant - To explore the effect of adding Cisplatin to the standard treatment on time to death by any cause - To describe the effect of adding Cisplatin to the standard treatment on late toxicity;Primary end point(s): local control rate | — |
Countries
Netherlands
Outcome results
None listed