Clinical Trial: Preliminary Results of Chemoradiation plus Modulated RF-Hyperthermia and HDR Brachytherapy for LACC
Presented at the European Society for Hyperthermic Oncology (ESHO) Congress
Sapienza University Pilot Study: HyDeep 600WM efficacy in Locally Advanced Cervical Carcinoma (LACC).
Authors: E. Clarke, V. De Sanctis, C. Scaringi, M. Valeriani, M. F. Osti, R. Maurizi Enrici
Sant’Andrea Hospital, Radiotherapy Dept, University of Rome “Sapienza”, Rome, Italy
Clinical Trial Abstract
AIMS
To investigate the outcome of chemoradiation plus modulated RF-hyperthermia (mHT) and high-dose-rate brachytherapy (BRT) for locally advanced cervix carcinoma (LACC). While chemoradiotherapy is the standard, adding deep regional hyperthermia to radiotherapy (RT) has shown to improve local tumour control and overall survival without affecting treatment-related grade 3 to 4 toxicity.
MATERIALS AND METHODS
A pilot study included patients with LACC or locally recurrent cervical carcinoma (LRCC). The treatment protocol utilized:
- Oncological Hyperthermia: Weekly sessions using the Andromedic HyDeep 600WM advanced oncologic hyperthermia device (13.56 MHz).
- Chemotherapy: Weekly Cisplatin (40mg/m2).
- Radiotherapy (IMRT): 50.4 Gy with SIB integrated boost to GTV for a total of 61.8 Gy.
- Brachytherapy (BRT): 21 Gy in 3 fractions (HDR).
KEY FINDINGS
All LACC patients achieved 100% local control.
No treatment-related acute or late grade 3 to 4 toxicity was observed. The HyDeep 600WM modulated RF hyperthermia device proved to be a safe and highly effective radio-sensitizer for pelvic tumors.
CONCLUSIONS
This regimen was well tolerated with an excellent clinical response. The addition of mHT to chemoradiotherapy represents a promising new strategy for cervical cancer management.
SCIENTIFIC REFERENCES
- 1. Lutgens L. et al. Hyperthermia and RT for LACC. Cochrane Database Syst Rev. 2010.
- 2. van der Zee J. et al. Radiotherapy plus hyperthermia in pelvic tumours. Lancet. 2000.
- 3. Green J. et al. Chemotherapy and radiation for uterine cervix cancer. Cochrane Database 2005.
Frequently Asked Questions
Q: How does HyDeep 600WM modulated RF hyperthermia device improve cervical cancer treatment?
A: The Andromedic mHT device uses 13.56 MHz modulated RF to selectively heat tumor tissue, increasing vasodilation and improving oxygenation thus making cancer cells more sensitive to radiotherapy and cisplatin, achieving 100% local control in clinical pilot studies.
Q: Does the addition of deep local hyperthermia increase radiotherapy side effects?
A: No. According to this ESHO 2014 hyperthermia study results, no grade 3 or 4 acute or late toxicities were registered when combining HyDeep 600WM deep local hyperthermia with IMRT and Brachytherapy.
Q: What is the significance of the “100% local control” achieved in this study?
A: It indicates that in all patients treated with the combination of HyDeep 600WM modulated RF-hyperthermia and standard chemoradiation, there was no tumor progression or recurrence within the treated pelvic area during the follow-up period. While one patient experienced distant metastasis (outside the pelvis), the local treatment successfully prevented the primary tumor from growing, demonstrating the high efficacy of radio-sensitization in the pelvic region.
Equip Your Clinic with HyDeep 600WM Advanced Oncologic Hyperthermia Technology