Effects of the addition of electro-hyperthermia (Oncothermia) to chemoradiotherapy in cancer of the cervix. Randomized clinical trial – Phase III.
Dr. Minara CA of the University of Witwatersrand, Johannesburg, South Africa has published in the journal Oncothermia journal 21:56 57, 2017 an update on the phase III randomized clinical trial investigating the effects of the addition of electrons hyperthermia to chemoradiotherapy for patients with cancer of the cervix in South Africa.
The electrohyperthermia (EHT) trial is an ongoing phase III randomized clinical trial that is conducted at the Charlotte Maxeke Johannesburg Academic Hospital. The overall objective is to determine the clinical effects of the addition of modulated electrohyperthermia (EHT) to standard treatment protocols for locally advanced cervical cancer patients in state health care in South Africa. The objectives are to evaluate the effects of the addition of EHT on local control of the disease, quality of life, acute and late toxicity and overall survival.
Methods:
The purpose of the study is to treat 236 women with a FIGO IIB to IIIB stage of cervical cancer. Participants are randomly assigned to a group of “Hyperthermia” (EHT plus chemoradiation) and a group of “Control” (chemoradiation alone), strata of randomization: HIV status; years; stage of the disease. All participants receive external radiation of 50 Gy, 3 doses of brachytherapy with a high dose rate of 8 Gy and cisplatin. The “Oncothermia” group receives two local EHT treatments of 55 minutes per week during radiation therapy. Local control of the disease is evaluated by positron emission tomography (PET) scans. Adverse events, quality of life and overall survival are recorded and the data analyzed.
Results:
The first 100 participants are evaluated until they reach 6 months after treatment.
There has been a positive trend in the survival and local control of the disease in the group receiving OT.
There are no significant differences in acute adverse events or quality of life between the two groups.
The preliminary results of the addition of EHT are positive without impact on adverse events, however, this should be confirmed with more patients at the end of the study.
