BSD-2000 Published Clinical Studies

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

Tumor Author Year Method No. of Patients Title Journal Abstract Link
Breast Cancer De-Colle 2019 RT+HT 20 Hyperthermic chest wall re-irradiation in recurrent breast cancer: a prospective observational study Strahlenther Onkol icon 48 article
Soft Tissue Sarcoma Issels 2018 CT vs.
CT+HT
341 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.  JAMA icon 48 article
Rectal Cancer Zwirner 2018 RCT+HT 86 External validation of a rectal cancer outcome prediction model with a cohort of patients treated with preoperative radiochemotherapy and deep regional hyperthermia IJH icon 48 article
Soft Tissue Sarcoma Angele 2014 CT vs.
CT+HT
341 Effectiveness of regional hyperthermia with chemotherapy for high-risk retroperitoneal and abdominal soft-tissue sarcoma after complete surgical resection: a subgroup analysis of a randomized phase-III multicenter study. Ann Surg Oncol icon 48 article
Pancreatic Cancer Tschoep-Lechner 2013 CT+HT 23 Gemcitabine and cisplatin combined with regional hyperthermia as second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer. IJH icon 48 article
Cervical Cancer Westermann 2012 RT+HT 68 Long-term survival data of triple modality treatment of stage IIB-III-IVA cervical cancer with the combination of radiotherapy, chemotherapy and hyperthermia - an update. IJH icon 48 article
Rectal Cancer Schroeder 2012 RCT vs.
RCT+HT
106 Pathological complete response and sphincter-sparing surgery after neoadjuvant radiochemotherapy with regional hyperthermia for locally advanced rectal cancer compared with radiochemotherapy alone. IJH icon 48 article
Cervical Cancer Heijkoop 2012 RCT+HT 43 Neoadjuvant chemotherapy followed by radiotherapy and concurrent hyperthermia in patients with advanced-stage cervical cancer: a retrospective study IJH icon 48 article
Pancreatic Cancer  Maluta 2011  RCT+HT  68 Regional hyperthermia combined with chemoradiotherapy in primary or recurrent locally advanced pancreatic cancer : an open-label comparative cohort trial Strahlenther Onkol icon 48 article 
Ovarian Cancer Fotopoulou 2010 CT+HT 36 Regional abdominal hyperthermia combined with systemic chemotherapy for the treatment of patients with ovarian cancer relapse: Results of a pilot study IJH icon 48 article
Soft Tissue Sarcoma Issels 2010 CT vs.
CT+HT
341 Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study. Lancet icon 48 article
Rectal Cancer Maluta 2010 RCT+HT 76 Regional hyperthermia added to intensified preoperative chemo-radiation in locally advanced adenocarcinoma of middle and lower rectum IJH icon 48 article
Soft Tissue Sarcoma Schlemmer 2010 RCT+HT 47 Thermochemotherapy in patients with extremity high-risk soft tissue sarcomas (HR-STS) IJH icon 48 article
Bladder Cancer Wittlinger 2009 RCT+HT 45 Quadrimodal treatment of high-risk T1 and T2 bladder cancer: transurethral tumor resection followed by concurrent radiochemotherapy and regional deep hyperthermia Radiother Oncol icon 48 article
Cervical Cancer Franckena 2009 RT vs.
RT+HT
378 Radiotherapy and hyperthermia for treatment of primary locally advanced cervix cancer: results in 378 patients IJRO icon 48 article
Rectal Cancer Milani 2008 RCT+RHT 24 Radiochemotherapy in combination with regional hyperthermia in preirradiated patients with recurrent rectal cancer Strahlenther Onkol icon 48 article
Cervical Cancer Franckena 2008 RT vs.
RT+HT
114 Long-term improvement in treatment outcome after radiotherapy and hyperthermia in locoregionally advanced cervix cancer: an update of the Dutch Deep Hyperthermia Trial.  IJRO icon 48 article
 Prostate Cancer Maluta  2007 CRT+HT 144 Conformal radiotherapy plus local hyperthermia in patients affected by locally advanced high risk prostate cancer: preliminary results of a prospective phase II study IJH   icon 48 article
Vaginal Cancer Aktas 2007 RT+HT 44 Concomitant radiotherapy and hyperthermia for primary carcinoma of the vagina: a cohort study. Eur J Obstet icon 48 article
Cervical Cancer Sreenivasa 2006 RCT+HT 32 Radiochemotherapy combined with regional pelvic hyperthermia induces high response and resectability rates in patients with nonresectable cervical cancer > or =FIGO IIB "bulky". IJRO icon 48 article
Ovarian Cancer Jones 2006 CT+HT 41 Intra-peritoneal cisplatin and whole abdomen hyperthermia for relapsed ovarian carcinoma IJH icon 48 article
Cervical Cancer Westermann 2005 RCT+HT 68 First results of triple-modality treatment combining radiotherapy, chemotherapy, and hyperthermia for the treatment of patients with stage IIB, III, and IVA cervical carcinoma. Cancer icon 48 article
Ovarian Cancer Hahn 2005 CT+HT 32 Prospective assessment of quality of life in ovarian cancer patients receiving whole abdomen hyperthermia and liposomal doxorubicin. IJH icon 48 article
Ovarian Cancer Alvarez Secord 2005 CT+HT 30 Phase I/II trial of intravenous Doxil and whole abdomen hyperthermia in patients with refractory ovarian cancer. IJH icon 48 article
Prostrate Cancer Tilly 2005 RT+HT 22 Regional hyperthermia in conjunction with definitive radiotherapy against recurrent or locally advanced prostate cancer T3 pN0 M0. Strahlenther Onkol icon 48 article
Technical Study Gellermann 2005   MRI Imaging Methods and potentials of magnetic resonance imaging for monitoring radiofrequency hyperthermia in a hybrid system IJH icon 48 article
Rectal Cancer Hildebrandt 2004 RT+HT 9 Regional pelvic hyperthermia as an adjunct to chemotherapy (oxaliplatin, folinic acid, 5-fluorouracil) in pre-irradiated patients with locally recurrent rectal cancer: a pilot study. IJH icon 48 article
Soft Tissue Sarcoma Fiegl 2004 CT+HT  20 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. IJH icon 48 article
Rectal Cancer Juffermans 2003 RT+HT 54 Reirradiation and hyperthermia in rectal carcinoma: a retrospective study on palliative effect. Cancer icon 48 article
Cervical Cancer Jones 2003 RT+HT 12 A pilot Phase II trial of concurrent radiotherapy, chemotherapy, and hyperthermia for locally advanced cervical carcinoma. Cancer icon 48 article
Prostate Cancer Kalapurakal 2003 RT+HT 13 Efficacy of irradiation and external hyperthermia in locally advanced, hormone-refractory or radiation recurrent prostate cancer: a preliminary report. IJRO icon 48 article
Cervical Cancer Van der Zee 2003 RT vs.
RT+HT
114 The Dutch Deep Hyperthermia Trial: results in cervical cancer IJH icon 48 article
Rectal Cancer Romano 2003 RT+HT 57 Pre-operative radio-chemotherapy plus regional hyperthermia in the treatment of advanced rectal cancer: experience with radiation dose escalation IJRO icon 48 article
Pediatric Tumors Wesslowski 2003 CT+HT 39 An approach for cure: PEI-chemotherapy and regional deep hyperthermia in children and adolescents with unresectable malignant tumors Klin Padiatr icon 48 article
Soft Tissue Sarcoma Wendtner 2002 CT+HT 58 Response to neoadjuvant chemotherapy combined with regional hyperthermia predicts long-term survival for adult patients with retroperitoneal and visceral high-risk soft tissue sarcomas. JCO icon 48 article
Soft Tissue Sarcoma Issels 2001 CT+HT 59 Neoadjuvant chemotherapy combined with regional hyperthermia (RHT) for locally advanced primary or recurrent high-risk adult soft-tissue sarcomas (STS) of adults: long-term results of a phase II study. Eur J Cancer icon 48 article
Germ Cell Tumors Schneider 2001 CT+HT 22 Treatment of recurrent malignant sacrococcygeal germ cell tumors: analysis of 22 patients registered in the German protocols MAKEI 83/86, 89, and 96. JCO icon 48 article
Soft Tissue Sarcoma Wendtner 2001 RCT+HT 54 Treatment of primary, recurrent or inadequately resected high-risk soft-tissue sarcomas (STS) of adults: results of a phase II pilot study (RHT-95) of neoadjuvant chemotherapy combined with regional hyperthermia. Eur J Cancer icon 48 article
Technical Study Maguire 2001  Thermal Dose  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 IJH icon 48 article
Prostate Cancer Kalapurakal 2001 RT+HT 3 Re-irradiation and external hyperthermia in locally advanced, radiation recurrent, hormone refractory prostate cancer: a preliminary report. Br J Radiol icon 48 article 
Technical Study Tilly 2001 Specific Absorbtion Rate Temperature data and specific absorption rates in pelvic tumours: predictive factors and correlations. IJH icon 48 article
Rectal Cancer Anscher 2000 CT+HT 15 A pilot study of preoperative continuous infusion 5-fluorouracil, external microwave hyperthermia, and external beam radiotherapy for treatment of locally advanced, unresectable, or recurrent rectal cancer. IJRO icon 48 article
Cervical Cancer Van der Zee  2000 RT vs.
RT+HT
114 Comparison of radiotherapy alone with radiotherapy plus hyperthermia in locally advanced pelvic tumors: a prospective, randomized, multicentre trial. Dutch Deep Hyperthermia Group Lancet icon 48 article
Rectal Cancer Rau 2000 RCT+HT 54 Preoperative radiochemotherapy in locally advanced or recurrent rectal cancer: regional radiofrequency hyperthermia correlates with clinical parameters. IJRO icon 48 article
Bladder Cancer Van der Zee 2000 MMC+RT vs.
RT+HT
101 Comparison of radiotherapy alone with radiotherapy plus hyperthermia in locally advanced pelvic tumors: a prospective, randomized, multicentre trial. Dutch Deep Hyperthermia Group  Lancet icon 48 article
Rectal Cancer Van der Zee 2000 RT vs.
RT+HT
143 Comparison of radiotherapy alone with radiotherapy plus hyperthermia in locally advanced pelvic tumors: a prospective, randomized, multicentre trial. Dutch Deep Hyperthermia Group Lancet icon 48 article
Soft Tissue Sarcoma Prosnitz 1999 RT+HT 97 The treatment of high-grade soft tissue sarcomas with preoperative thermoradiotherapy. IJRO icon 48 article
Cervical Cancer de Wit 1999 CT+HT 19 A phase I/II study of combined weekly systemic cisplatin and locoregional hyperthermia in patients with previously irradiated recurrent carcinoma of the uterine cervix. Br J Radiol icon 48 article
Germ Cell Tumor Wessalowski 1998 CT+HT 7 Hyperthermia for the treatment of patients with malignant germ cell tumors: a phase I/II study in ten children and adolescents with recurrent or refractory tumors Cancer icon 48 article
Rectal Cancer Rau 1998 RCT+HT 37 Preoperative hyperthermia combined with radiochemotherapy in locally advanced rectal cancer: a phase II clinical trial. Ann Surg Oncol icon 48 article
Germ Cell Tumor Wessalowski 1997 CT+HT 9 Treatment results in children and adolescents with loco-regional recurrences of abdominal germ cell tumors (GCTs): a pilot-study with PEI chemotherapy and regional deep hyperthermia (RHT) in comparison to a matched cohort Klin Padiatr icon 48 article
Prostate Anscher 1997 RT+HT 30 Combined external beam irradiation and external regional hyperthermia for locally advanced adenocarcinoma of the prostate. IJRO icon 48 article
Deep Tumors Myerson 1996 RT+HT 66 A phase I/II study to evaluate radiation therapy and hyperthermia for deep-seated tumours: a report of RTOG 89-08. IJH icon 48 article
Soft Tissue Sarcoma Scully 1994 RT+HT 40 Clinical outcome after neoadjuvant thermoradiotherapy in high grade soft tissue sarcomas J Surg Oncol icon 48 article
Head & Neck Cancer Valdagni 1994 RT vs.
RT+LHT
44 Radical radiation alone versus radical radiation plus microwave hyperthermia for N3 (TNM-UICC) neck nodes: a prospective randomized clinical trial. IJRO  icon 48 article
Technical Study Feldmann 1993 Temperature Deep regional hyperthermia: comparison between the annular phased array and the sigma-60 applicator in the same patients. IJRO icon 48 article
Prostate Kaplan 1991 RT+HT 6 Secondary external-beam radiotherapy and hyperthermia for local recurrence after 125-iodine implantation in adenocarcinoma of the prostate IJRO icon 48 article
Genitourinary Cancer

Petrovich

1991 RT vs.
RT+HT
53 Regional hyperthermia in patients with recurrent genitourinary cancer. Am J Clin Oncol icon 48 article
Technical Study Myerson 1991   Phantom Phantom studies and preliminary clinical experience with the BSD 2000 IJH icon 48 article
Soft Tissue Sarcoma Issels 1990 CT+HT 40 Ifosfamide plus etoposide combined with regional hyperthermia in patients with locally advanced sarcomas: a phase II study. JCO icon 48 article

RT-Radiotherapy; HT-Hyperthermia; LHT-Local Hyperthermia; CHT-Chemothyperthermia; CTX-Chemotherapy; MMC-Mitomycin C; EHT; Endocavity Hyperthermia; IHT-Interstitial Hyperthermia; HIPEC-Heated Intraperitoneal Chemotherapy; RCT-RadioChemotherapy; BCG-Bacillus Calmette-Guerin; CRT-Conformal Radiotherapy

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.