BSD-2000 Clinical Studies

Authors: Gellermann J, Wlodarczyk W, Feussner A, Fähling H, Nadobny J, Hildebrandt B, Felix R, Wust P.
Publication: Int J Hyperthermia. 2005 Sep;21(6):497-513.

INTRODUCTIONS:
Non-invasive thermometry (NIT) is a valuable and probably indispensable tool for further development of radiofrequency (RF) hyperthermia. A hybridization of an MRI scanner with a hyperthermia system is necessary for a real-time NIT. The selection of the best thermographic method is difficult, because many parameters and attributes have to be considered.

Authors: Maguire PD, Samulski TV, Prosnitz LR, Jones EL, Rosner GL, Powers B, Layfield LW, Brizel DM, Scully SP, Harrelson JM, Dewhirst MW.
Publication: Int J Hyperthermia. 2001 Jul-Aug;17(4):283-90.

PURPOSE:
We prospectively evaluated whether delivering a thermal dose of > 10 cumulative equivalent minutes at 43 degrees C to >90% of the tumour sites monitored (CEM43 degrees T90) would produce a pathologic complete response (pCR) in > 75% of high-grade soft tissue sarcomas treated pre-operatively with thermoradiotherapy.

Authors: Maluta S, Dall'Oglio S, Romano M, Marciai N, Pioli F, Giri MG, Benecchi PL, Comunale L, Porcaro AB
Publication: Int J Hyperthermia. 2007 Aug;23(5):451-6.

PURPOSE:
Hyperthermia has been used in several trials to treat pelvic cancers without excessive toxicity and with positive results. The aim of this study was to evaluate feasibility and results in terms of biochemical recurrence-free, disease-free survival, overall survival, and treatment toxicity profile of hyperthermia combined with radiotherapy in locally advanced high risk prostate cancer.

Authors: Heijkoop ST, Franckena M, Thomeer MG, Boere IA, Van Montfort C, Van Doorn HC.
Publication: Int J Hyperthermia. 2012;28(6):554-61. doi: 10.3109/02656736.2012.674622. Epub 2012 Jun 12.

OBJECTIVE:
To evaluate the efficacy of neoadjuvant chemotherapy, followed by radiotherapy and concurrent hyperthermia (triple therapy) in patients with advanced-stage cervical cancer.

Authors: Maluta S, Schaffer M, Pioli F, Dall'oglio S, Pasetto S, Schaffer PM, Weber B, Giri MG.
Publication: Strahlenther Onkol. 2011 Oct;187(10):619-25. doi: 10.1007/s00066-011-2226-6. Epub 2011 Sep 19.

PURPOSE:
To evaluate the therapeutic effect of delivering regional hyperthermia (HT) plus chemoradiotherapy (CRT) in patients suffering from locally advanced unresectable pancreatic cancer (LAPC).

Authors: Schneider DT, Wessalowski R, Calaminus G, Pape H, Bamberg M, Engert J, Waag K, Gadner H, Göbel U.
Publication: J Clin Oncol. 2001 Apr 1;19(7):1951-60.

PURPOSE:

To evaluate therapeutic options for recurrent malignant sacrococcygeal germ cell tumors (GCT) following three-agent, cisplatinum-based, first-line chemotherapy and tumor resection.

Authors: Maluta S, Romano M, Dall'oglio S, Genna M, Oliani C, Pioli F, Gabbani M, Marciai N, Palazzi M.
Publication: Int J Hyperthermia. 2010;26(2):108-17. doi: 10.3109/02656730903333958.

PURPOSE:
To evaluate the safety of delivering pre-operative regional hyperthermia (HT) plus an intensified chemo-radiotherapy (CRT) regimen in patients suffering from locally advanced rectal cancer.

Table Article Count: 12

Page 3 of 9

BSD-2000 Published Clinical Studies

Phase I, II & III Clinical Studies that used the BSD-2000

Methods and potentials of magnetic resonance imaging for monitoring radiofrequency hyperthermia in a hybrid system

A phase II trial testing the thermal dose parameter CEM43 degrees T90 as a predictor of response in soft tissue sarcomas treated with pre-operative thermoradiotherapy

Conformal radiotherapy plus local hyperthermia in patients affected by locally advanced high risk prostate cancer: preliminary results of a prospective phase II study

Neoadjuvant chemotherapy followed by radiotherapy and concurrent hyperthermia in patients with advanced-stage cervical cancer: a retrospective study

Regional hyperthermia combined with chemoradiotherapy in primary or recurrent locally advanced pancreatic cancer : an open-label comparative cohort trial

Treatment of recurrent malignant sacrococcygeal germ cell tumors: analysis of 22 patients registered in the German protocols MAKEI 83/86, 89, and 96.

Regional hyperthermia added to intensified preoperative chemo-radiation in locally advanced adenocarcinoma of middle and lower rectum

Table Article Count: 12