A Randomized Phase II Study Of Reirradiation And Hyperthermia Versus Reirradiation And Hyperthermia Plus Chemotherapy For Locally Recurrent Breast Cancer In Previously Irradiated Area

Phase 2

Completed

• Conditions: Breast cancer; breast carcinoma; 10006291

• Registration Number: NL-OMON34632
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 104

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.

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* local control rate </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* acute toxicity: grade 4 dermatitis (ulceration/ necrosis), induced by<br /><br>treatment, requiring reconstructive surgery and/or hyperbaric oxygen<br /><br>* clinical complete response rate<br /><br>* disease free survival<br /><br>* overall survival<br /><br>* actuarial late toxicity</p><br>