BSD-2000 Published Clinical Studies

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

Authors: Sreenivasa G, Hildebrandt B, Kümmel S, Jungnickel K, Cho CH, Tilly W, Böhmer D, Budach V, Felix R, Wust P.
Publication: Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):1159-67. Epub 2006 Sep 18.

To evaluate preoperative radiochemotherapy combined with regional pelvic hyperthermia in patients with nonresectable cervical cancer >/= International Federation of Gynecology and Obstetrics (FIGO) IIB "bulky" in a Phase II study.

Authors: M Romano, S Maluta, C Cordiano, G.G Delaini, M Genna, C Oliani, P Capelli, A Tomezzolli, C Manfrini, A.B Porcaro, M Gabbani, G Chierego
Publication: International Journal of Radiation Oncology, October 1, 2003Volume 57, Issue 2, Supplement, Pages S386–S387

To evaluate toxicity and pathological complete response rate in treating preoperatively rectal cancer patients by radiation dose escalation combined with RH + CT.

Authors: Alvarez Secord A, Jones EL, Hahn CA, Petros WP, Yu D, Havrilesky LJ, Soper JT, Berchuck A, Spasojevic I, Clarke-Pearson DL, Prosnitz LR, Dewhirst MW.
Publication: Int J Hyperthermia. 2005 Jun;21(4):333-47.

A phase I/II study of Doxil combined with whole abdomen hyperthermia was conducted in patients with refractory ovarian cancer. Liposomal doxorubicin combined with hyperthermia has been shown to increase both liposomal delivery and drug extravasation into tumour xenografts resulting in enhanced cytotoxic effects.

Authors: Rau B, Wust P, Hohenberger P, Löffel J, Hünerbein M, Below C, Gellermann J, Speidel A, Vogl T, Riess H, Felix R, Schlag PM.
Publication: Ann Surg. 1998 Mar;227(3):380-9. Review.

A prospective phase II study was performed to determine the feasibility and efficacy in terms of response rate, resectability, and morbidity in patients with locally advanced rectal cancer who received preoperative regional hyperthermia combined with radiochemotherapy (HRCT).

Authors: Prosnitz LR, Maguire P, Anderson JM, Scully SP, Harrelson JM, Jones EL, Dewhirst M, Samulski TV, Powers BE, Rosner GL, Dodge RK, Layfield L, Clough R, Brizel DM.
Publication: Int J Radiat Oncol Biol Phys. 1999 Nov 1;45(4):941-9.

To explore the use of a novel program of preoperative radiation and hyperthermia in the management of high-grade soft tissue sarcomas (STS).

Authors: Rau B, Wust P, Tilly W, Gellermann J, Harder C, Riess H, Budach V, Felix R, Schlag PM.
Publication: Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):381-91.

Preoperative radiochemotherapy (RCT) is a widely used means of treatment for patients suffering from primary, locally advanced, or recurrent rectal cancer. We evaluated the efficacy of treatment due to additional application of regional hyperthermia (HRCT) to this conventional therapy regime in a Phase II study, employing the annular phased-array system BSD-2000 (SIGMA-60 applicator). The clinical results of the trial were encouraging. We investigated the relationship between a variety of thermal and clinical parameters in order to assess the adequacy of thermometry, the effectiveness of hyperthermia therapy, and its potential contribution to clinical endpoints.