BSD-2000 Published Clinical Studies

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

Authors: Issels RD, Lindner LH, Verweij J, Wust P, Reichardt P, Schem BC, Abdel-Rahman S, Daugaard S, Salat C, Wendtner CM, Vujaskovic Z, Wessalowski R, Jauch KW, Dürr HR, Ploner F, Baur-Melnyk A, Mansmann U, Hiddemann W, Blay JY, Hohenberger P; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group (EORTC-STBSG); European Society for Hyperthermic Oncology (ESHO).
Publication: Lancet Oncol. 2010 Jun;11(6):561-70. doi: 10.1016/S1470-2045(10)70071-1. Epub 2010 Apr 29.

BACKGROUND:
The optimum treatment for high-risk soft-tissue sarcoma (STS) in adults is unclear. Regional hyperthermia concentrates the action of chemotherapy within the heated tumour region. Phase 2 studies have shown that chemotherapy with regional hyperthermia improves local control compared with chemotherapy alone. We designed a parallel-group randomised controlled trial to assess the safety and efficacy of regional hyperthermia with chemotherapy.

Authors: van der Zee J, González GD.
Publication: Int J Hyperthermia. 2002 Jan-Feb;18(1):1-12.

BACKGROUND:
Radiotherapy plus hyperthermia was compared to radiotherapy alone in the Dutch Deep Hyperthermia Trial, in patients with advanced bladder, cervical, and rectal tumours. The overall results, published elsewhere, demonstrate that addition of hyperthermia to radiotherapy improves both pelvic control and overall survival rates. The therapeutic gain appeared especially worthwhile in locally advanced cervical tumours. Here, the results in patients with cervical cancer are summarized and discussed, and further details provided.

Authors: Franckena M, Stalpers LJ, Koper PC, Wiggenraad RG, Hoogenraad WJ, van Dijk JD, Wárlám-Rodenhuis CC, Jobsen JJ, van Rhoon GC, van der Zee J.
Publication: Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1176-82. Epub 2007 Sep 19.

PURPOSE:
The local failure rate in patients with locoregionally advanced cervical cancer is 41-72% after radiotherapy (RT) alone, whereas local control is a prerequisite for cure. The Dutch Deep Hyperthermia Trial showed that combining RT with hyperthermia (HT) improved 3-year local control rates of 41-61%, as we reported earlier. In this study, we evaluate long-term results of the Dutch Deep Hyperthermia Trial after 12 years of follow-up.

Authors: Franckena M, Lutgens LC, Koper PC, Kleynen CE, van der Steen-Banasik EM, Jobsen JJ, Leer JW, Creutzberg CL, Dielwart MF, van Norden Y, Canters RA, van Rhoon GC, van der Zee J.
Publication: Int J Radiat Oncol Biol Phys. 2009 Jan 1;73(1):242-50. doi: 10.1016/j.ijrobp.2008.03.072. Epub 2008 Nov 5.

PURPOSE:
To report response rate, pelvic tumor control, survival, and late toxicity after treatment with combined radiotherapy and hyperthermia (RHT) for patients with locally advanced cervical carcinoma (LACC) and compare the results with other published series.

Authors: van der Zee J, González González D, van Rhoon GC, van Dijk JD, van Putten WL, Hart AA.
Publication: Lancet. 2000 Apr 1;355(9210):1119-25.

BACKGROUND:
Local-control rates after radiotherapy for locally advanced tumours of the bladder, cervix, and rectum are disappointing. We investigated the effect of adding hyperthermia to standard radiotherapy.

Authors: Angele MK, Albertsmeier M, Prix NJ, Hohenberger P, Abdel-Rahman S, Dieterle N, Schmidt M, Mansmann U, Bruns CJ, Issels RD, Jauch KW, Lindner LH.
Publication: Ann Surg. 2014 Nov;260(5):749-54; discussion 754-6. doi: 10.1097/SLA.0000000000000978.

OBJECTIVE:
To determine whether regional hyperthermia (RHT) in addition to chemotherapy improves local tumor control after macroscopically complete resection of abdominal or retroperitoneal high-risk sarcomas.

Authors: Issels RD, Lindner LH, Verweij J, Wessalowski R, Reichardt P, Wust P, Ghadjar P, Hohenberger P, Angele M, Salat C, Vujaskovic Z, Daugaard S, Mella O, Mansmann U, Dürr HR, Knösel T, Abdel-Rahman S, Schmidt M, Hiddemann W, Jauch KW, Belka C, Gronchi A; European Organization for the Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group and the European Society for Hyperthermic Oncology.
Publication: JAMA Oncol. 2018 Feb 15. doi: 10.1001/jamaoncol.2017.4996.

IMPORTANCE:
Patients with soft tissue sarcoma are at risk for local recurrence and distant metastases despite optimal local treatment. Preoperative anthracycline plus ifosfamide chemotherapy improves outcome in common histological subtypes.