BSD-2000 Published Clinical Studies

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

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).

METHODS and MATERIALS:
Between January 2000 and December 2008, 68 patients affected by primary (56/68) or recurrent (12/68) LAPC were treated either with CRT alone or CRT plus HT. Radiotherapy (RT) consisted of 3D conformal irradiation of tumor and regional lymph nodes (dose ranged from 30 Gy/10 fractions to 66 Gy/33 fractions). Chemotherapy (CT) consisted of gemcitabine (GEM) alone or in association with either oxaliplatin, cisplatin, or 5-FU. HT was delivered twice a week, concomitant with RT.

RESULTS:
In the current study, 60 of the original 68 patients were included. Median overall survival (OS) was 15 months in the HT group versus 11 months in the control group (log-rank test: p = 0.025). HT did not increase CRT toxicity.

CONCLUSIONS:
HT can be added safely to CRT in LAPC, thus, resulting in slightly prolonged survival in certain cases.

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