BSD-2000 Clinical Studies

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.

Authors: Petrovich Z, Emami B, Kapp D, Sapozink MD, Langholz B, Oleson J, Lieskovsky G, Astrahan M.
Publication:Am J Clin Oncol. 1991 Dec;14(6):472-7.

PURPOSE:
During a 6-year period, 53 patients with advanced tumors of the genitourinary tract were treated in Phase I protocols with deep regional hyperthermia in combination with irradiation (83%) or in combination with chemotherapy (11%).

Authors: Milani V, Pazos M, Issels RD, Buecklein V, Rahman S, Tschoep K, Schaffer P, Wilkowski R, Duehmke E, Schaffer M.
Publication: Strahlenther Onkol. 2008 Mar;184(3):163-8. doi: 10.1007/s00066-008-1731-8.

PURPOSE:
Encouraging results of phase II studies combining chemotherapy with radiotherapy have been published. In this study, the results of a multimodal salvage therapy including radiochemotherapy (RCT) and regional hyperthermia (RHT) in preirradiated patients with recurrent rectal cancer are reported.

Authors: Zwirner K, Bonomo 2, Lamprecht U, Zips D, Gani C.
Publication: Int J Hyperthermia. 2018 Jun;34(4):455-460. doi: 10.1080/02656736.2017.1338364. Epub 2017 Jul 26.

PURPOSE:
To validate a nomogram for the prediction of treatment outcomes after preoperative radiochemotherapy and surgery for locally advanced rectal cancer with a cohort of patients treated with additional deep regional hyperthermia.

Authors: Jones E, Alvarez Secord A, Prosnitz LR, Samulski TV, Oleson JR, Berchuck A, Clarke-Pearson D, Soper J, Dewhirst MW, Vujaskovic Z.
Publication: Int J Hyperthermia. 2006 Mar;22(2):161-72.

PURPOSE:
The study was designed to determine the maximum tolerated dose (MTD) of IP cisplatin [CDDP] combined with intravenous thiosulphate and concurrent whole abdomen hyperthermia for advanced, recurrent or progressive ovarian carcinoma..

Authors: Tschoep-Lechner KE, Milani V, Berger F, Dieterle N, Abdel-Rahman S, Salat C, Issels RD.
Publication: Int J Hyperthermia. 2013;29(1):8-16. doi: 10.3109/02656736.2012.740764. Epub 2012 Dec 17.

PURPOSE:
There is no standard second-line therapy for patients with advanced pancreatic cancer (APC) after gemcitabine (G) failure. Cisplatin (Cis)-based chemotherapy has shown activity in APC. It is proven that cytotoxicity of G and Cis is enhanced by heat exposure at 40° to 42°C. Therefore G plus Cis with regional hyperthermia (RHT) might be beneficial for patients with G-refractory APC.

Authors: Fiegl M, Schlemmer M, Wendtner CM, Abdel-Rahman S, Fahn W, Issels RD.
Publication: Int J Hyperthermia. 2004 Sep;20(6):661-70.

PURPOSE:
To evaluate the efficacy and safety of the combination of ICE (ifosfamide 1.5 g m(-2), carboplatin 100 mg m(-2) and etoposide 150 mg m(-2), days 1-4, q 28 days, G-CSF 5 microg kg(-1) starting from day 6) alone and in combination with regional hyperthermia (RHT) in soft tissue sarcoma (STS) refractory to previous standard doxorubicin-ifosfamide-based chemotherapy.

Table Article Count: 12

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BSD-2000 Published Clinical Studies

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

Effect of Neoadjuvant Chemotherapy Plus Regional Hyperthermia on Long-term Outcomes Among Patients With Localized High-Risk Soft Tissue Sarcoma: The EORTC 62961-ESHO 95 Randomized Clinical Trial.

Regional hyperthermia in patients with recurrent genitourinary cancer

Radiochemotherapy in combination with regional hyperthermia in preirradiated patients with recurrent rectal cancer

External validation of a rectal cancer outcome prediction model with a cohort of patients treated with preoperative radiochemotherapy and deep regional hyperthermia

Intra-peritoneal cisplatin and whole abdomen hyperthermia for relapsed ovarian carcinoma

Gemcitabine and cisplatin combined with regional hyperthermia as second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer.

Ifosfamide, carboplatin and etoposide (ICE) as second-line regimen alone and in combination with regional hyperthermia is active in chemo-pre-treated advanced soft tissue sarcoma of adults

Table Article Count: 12