Update: Phase III randomised trial on electro-hyperthermia and chemoradiation in locally advanced cervical cancer
C.A. Minnaar1; J.A. Kotzen1; A. Baeyens1 2
1 Department of Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa
2 Department of Basic Medical Sciences, Ghent University, Belgium
OBJECTIVES: To determine the clinical effects of the addition of modulated electro-hyperthermia to the standard treatment protocols for locally advanced cervical cancer patients in state healthcare in South Africa. The measured outcomes are local disease control, quality of life, early and late toxicity and 2 year survival.
METHOD: This ongoing phase III randomised clinical trial is being conducted at the Charlotte Maxeke Johannesburg Academic Hospital. The study aims to enrol 236 female participants with FIGO stage IIB (initial distal parametrium involvement) to IIIB cervical cancer (bilateral hydronephrosis excluded). Participants are being randomised into a “Hyperthermia” group (mEHT plus chemoradiation) and a “Control” group (chemoradiation alone). Randomisation stratum: HIV status, age and stage of disease. Participants in both groups are receiving 25 fractions of 2Gy external beam radiation, 3 doses of high dose rate brachytherapy (8Gy) and up to 3 doses of cisplatin (80mg/m2). Two local mEHT sessions are administered per week prior to radiotherapy in the Hyperthermia group. Local disease control is assessed by Positron Emission Tomography (PET) scans and early toxicity is graded according to the CTCAE version 4.
RESULTS: We report on the interim analysis on local disease control and early toxicity of the first half of the recruited participants in our study. Early results show an improvement in local disease control with no unexpected early toxicity in the hyperthermia group.
CONCLUSION: There is a positive trend in the Hyperthermia group suggesting that the addition of hyperthermia may be beneficial in locally advanced cervical cancer patients.