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

• Conditions: recurrence breast cancer; Hyperthermia; Reirradiation; Cisplatin; PET-CT; recidief mammacarcinoom; Hyperthermie; herbestraling

• Registration Number: NL-OMON27367
• Lead Sponsor: Academic Medical Centre Amsterdamdepartment of Radiotherapy/ Radiation Oncologyprof. C.C.E.KoningThe Netherlands

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Macroscopic local regional recurrence of breast cancer in previously irradiated area, not suitable for resection;

2. Recurrence is measurable by clinical examination and/or radiological (CT-scan, MRI or ultrasound) assessment;

Exclusion Criteria

1. Concurrent chemotherapy other than study medication;

2. Uncontrolled infection;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal control rate.

Secondary Outcome Measures

Name	Time	Method
1. Acute toxicity: Grade 4 dermatitis (ulceration/ necrosis), induced by treatment, requiring reconstructive surgery and/or hyperbaric oxygen;<br /><br>2. Clinical complete response rate;<br /><br>3. Disease free survival;<br /><br>4. Overall survival;<br /><br>5. Actuarial late toxicity.