Clinical trials

Although, in contrast to the pharmaceutical industry, the medical hyperthermia sector currently has much smaller funds for financing clinical trials, their number is growing dynamically in recent years. Of all the above-mentioned clinical trials, only five were entirely financed by the equipment manufacturers, and all other by research centers. The niche character of the hyperthermia apparatus industry is one of the limiting factors. Such a barrier does not apply, for example, to the pharmaceutical industry. For this reason, the initiatives of the scientific community are extremely important for the progress of research. One of such initiatives is the research club called „Azelsberger Kreis für Hyperthermie”, which has been operating for many years, and international meetings are held every few months in Erlangen. One of the important sponsors of clinical trials on hyperthermia is ESHO – European Society of Hyperthermia Oncological.

Selection of clinical studies on hyperthermia

Abbreviations: RT Radiotherapy, CT Chemotherapy, HT Hiperthermia, FM Multimodal therapy, CR Complete response, PFS Progression free survival, OS Overall survival, DFS Disease free survival, S mean survival, NED No evidence of disease, HDRS Hamilton depression rating score, AP Affective pain, SP Sensorial pain, FIQ Pain intensity

Reference	Treatment	Indication	lesions	End point	-HT	+HT	HT type	Link
Merten (2019)	RT+CT	Bladder cancer	369	CR S 5 years S 10 years DFS	86% 64% 39% 40%	87% 87% 60% 66%	Local
Harima (2016)	RT+CT	Cervical cancer	101	CR S 5 years DFS 5 years	77,6% 64,8% 60,6%	88% 77,8% 70,8%	Local
Janssen (2016)	Brak	Major depressive disorder	34	HDRS	17,21	12,40	Whole body
Hua (2011)	RT+CT	Nasopharynx cancer	180	DFS 5 years	63%	73%	Local
Huilgol (2010)	RT	Head & neck cancer	54	CR	42%	79%	Local
Issels (2010)	CT	Soft tissue sarcoma	340	PFS	162 mon.	317 mon.	Local
Brockow (2007)	FM	Fibromyalgia	139	AP SP FIQ	-3,1 +0,4 +0,1	-8,2 -3,7 -1,6	Whole body
Jones (2005)	RT	Różne nowotwory	109	CR	42%	64%	Local
Colombo (2003)	CT	Bladder cancer	75	OS 2 years	40%	83%	Local
Verwaal (2003)	CT (Hipec)	Colorectal peritoneal carcinomatosis	105	S	126 mon.	223 mon.	Local
Harima (2001)	RT	Cervical cancer	40	CR	50%	85%	Local
Van der Zee (2000)	RT	Bladder, cervix & rectum cancer	358	OS 3 years	24%	30%	Local
Sneed (1998)	RT	Glioblastoma	112	S 2 years	15%	31%	Local
Vernon (1996)	RT	Breast cancer	39	CR	39%	79%	Local
Wang (1996)	RT	Oesophagus cancer	125	S 3 years	24%	42%	Local
Overgaard (1995)	RT	Melanoma	134	NED 2 years	28%	48%	Local

Response rate of RT alone vs RT+HT – Statistical approach