ESHO 2014: Clinical Validation

At the European Society for Hyperthermic Oncology (ESHO) 2014 Congress, landmark clinical data was presented validating the high efficacy, safety, and operational feasibility of the HyDeep 600 WM advanced modulated RF hyperthermia device in multimodal cancer care.

1. Chemoradiation + Hyperthermia + HDR Brachytherapy for LACC

AIMS: To investigate the clinical outcome of combining weekly cisplatin and deep local hyperthermia (using the HyDeep 600 WM) with Intensity-Modulated Radiation Therapy (IMRT) followed by Brachytherapy (BRT) for Locally Advanced Cervical Carcinoma (LACC).

Materials and Methods:

  • Patient Group: 8 patients (3 stage IIB, 1 IIIB, 2 NEI, 3 LRCC).
  • Radiotherapy Protocol: 50.4 Gy to pelvic nodes with SIB to GTV (61.8 Gy total) in 28 fractions. BRT dose: 21 Gy in 3 fractions.
  • Concurrent Therapy: Weekly Cisplatin 40mg/m² + Deep Local Hyperthermia once per week.

RESULTS & CONCLUSIONS:

100% LOCAL CONTROL ACHIEVED.

No treatment-related acute or late grade 3 to 4 toxicity was observed.

“The addition of deep local hyperthermia to chemoradiotherapy represents a promising new strategy with excellent tolerance.”

2. Quasi Feasibility Study (Case-Control) – Andalusia, Spain

Introduction: This represents a premier clinical trial in Spain evaluating the combination of deep local hyperthermia with standard cancer treatments within the public health system infrastructure.

  • Trial Design: Prospective, case-control study evaluating 293 total patients (97 active phase vs. 196 controls) across 9 different tumor locations.
  • Treatment Parameters: 10 sessions (2-3/week), 1-hour duration, utilizing 150W–400W of power delivered by the HyDeep 600 WM modulated hyperthermia device.

Preliminary Data (22 Patient Sub-set):

The patient subset included diverse and highly complex oncological indications: Glioblastoma, Head & Neck, Preoperative Rectum, Breast Cancer, NSCLC Lung Cancer, Prostate, and Cervical Metastasis.

81.2%
HIGH TOLERANCE

Patients reported being satisfied or very satisfied.

66.6%
ZERO TOXICITY

No adverse effects reported during or after sessions.

CONCLUSION: Deep local hyperthermia is highly feasible in routine public hospital care without requiring extraordinary resources. Proper patient selection ensures minimal (Grade 1) toxicity and excellent compliance.

Download Full Study Protocol (PDF)

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