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Introduction
The Electro-Hyperthermia trial an ongoing phase III randomised clinical trial being
conducted at the Charlotte Maxeke Johannesburg Academic Hospital. The general aim
is to determine the clinical effects of the addition of modulated electro-hyperthermia
(EHT) to the standard treatment protocols for locally advanced cervical cancer patients
in state healthcare in South Africa. The objectives are to assess the effects of the
addition of EHT on local disease control, quality of life, acute and late toxicity
and overall survival.
Materials and methods
The study aims to enrol 236 female participants with FIGO stage IIB distal to IIIB
cervical cancer. Participants are being randomised into a “Hyperthermia” group (EHT
plus chemoradiation) and a “Control” group (chemoradiation alone), randomisation stratums:
HIV status; age; stage of disease. All participants are receiving 50 Gy external beam radiation, 3 doses of high dose rate brachytherapy (8 Gy) and cisplatin. The Hyperthermia group is receiving two 55 minute local EHT treatments
per week during radiation therapy. Local disease control is being assessed by Positron
Emission Tomography (PET) scans. Adverse events, quality of life and overall survival
are being recorded and the data is being analysed.
Results
We report preliminary data of the first 100 participants to reach 6 months post treatment.
We see a positive trend in survival and local disease control in the group receiving
hyperthermia. There are no significant differences in acute adverse events or quality
of life between the groups.
Conclusion
The preliminary results on the addition of EHT are positive with no impact on adverse
events, however this must be confirmed with more patients on completion of the study.
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