Modulated Electro-Hyperthermia Plus Chemo-radiation for Locally Advanced Cervical Cancer Patients in South Africa
Status:
Unknown status
Trial end date:
2020-07-31
Target enrollment:
Participant gender:
Summary
This is a phase III randomised clinical trial. The aim is to investigate the clinical effects
of the addition of modulated electro-hyperthermia (mEHT) to standard treatment protocols
(chemoradiotherapy, CRT) for Human Immunodeficiency Virus (HIV) positive and negative locally
advanced cervical cancer patients (LACC). SAMPLE: The investigators aim to enrol 236 HIV
negative and HIV positive women with LACC, FIGO (Fédération Internationale de Gynécologie et
d'Obstétrique) Stages IIB (distil) to stage III. Participants will be randomly assigned to a
control group (N=118) and a study group (N=118). METHODOLOGY: Randomisation is based on age,
stage and HIV. Participants from both groups will receive the standard treatment for cervical
cancer at the hospital at the Charlotte Maxeke Johannesburg Academic Hospital in South
Africa: Up to three doses of 80mg/m2 cisplatin, administered three weeks apart; 50Gy external
beam radiation (EBR) in fractions of 2Gy; Three doses of 8Gy High Dose Rate (HDR)
brachytherapy. The study group will have two 55 minute mEHT treatments per week, at 130W,
directly before the EBR using the EHY 2000 Device. OUTCOMES: 1) Determine the local disease
control after treatment at 6 months using a Positron Emission Tomography (PET) and
computerised tomography (CT) scans. 2) Determine the progression-free survival (PFS) at 6,
12, 18 and 24 months after the last treatment date. PFS will be assessed in all registered
participants, regardless of completion (Intent to Treat-ITT) as well as only in the subset of
participants who complete the prescribed CRT. 3) Overall survival at two years will be
assessed. 4) To evaluate the adverse events associated with mEHT. 5) The effect of mEHT on
chemotherapy and radiotherapy tolerability and toxicity will be evaluated. 6) The quality of
life of enrolled participants will be assessed before, at 6 weeks, and at 3, 6, 9, 12, 18 and
24 months after completion of therapy using the EORTC (European Organisation for Research and
Treatment of Cancer) and EuroQoL forms. 7) To evaluate the economic viability of the addition
of mEHT to standard treatment protocols for LACC. 8) The effect, if any, of mEHT treatments
on the HIV disease status of HIV positive patients will be assessed by the presence of
Autoimmune Deficiency Syndrome (AIDS) defining illnesses before and after treatment. 9) The
cancer recurrence patterns will be described and compared in all the participants.
Phase:
Phase 3
Details
Lead Sponsor:
Jeffrey Kotzen
Collaborators:
National Research Foundation of South Africa NTP Radioisotopes SOC Ltd