BSD-2000 Published Clinical Studies

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

Abdominal

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Abdominal	Angele	2014	CT+HT	149	Effectiveness of Regional Hyperthermia With Chemotherapy for High-Risk Retroperitoneal and Abdominal Soft-Tissue Sarcoma After Complete Surgical Resection	Ann Surg Onc
Abdominal	Cho	2007	CT+HT	45	Regional hyperthermia of the abdomen in conjunction with chemotherapy for peritoneal carcinomatosis: Evaluation of two annular-phased-array applicators	Int J Hyperthermia

Breast

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Breast	Stoetzer	2020	CT+HT	53	Post-Neoadjuvant Gemcitabine and Cisplatin with Regional Hyperthermia for Patients with Triple-Negative Breast Cancer and Non-pCR after Neoadjuvant Chemotherapy: A Single-Institute Experience	Karger
Breast	De-Colle	2019	RT+HT	20	Hyperthermic chest wall re-irradiation in recurrent breast cancer: a prospective observational study	Strahlenther Onkol
Breast	Müller	2011	RT+HT	42	Re-surgery and chest wall re-irradiation for recurrent breast cancer - a second curative approach	BMC Cancer
Breast	Hehr	2001	HT	#	Thermoradiotherapy for locally recurrent breast cancer with skin involvement	Int J Hyperthermia

Bladder

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Bladder	Wen	2021	CT+HT	43	Loco-regional deep hyperthermia combined with intravesical Mitomycin instillation reduces the recurrence of non-muscle invasive papillary bladder cancer	Int J Hyperthermia
Bladder	Brummelhuis	2021	CRT+HT	274	Long-Term Experience with Radiofrequency-Induced Hyperthermia Combined with Intravesical Chemotherapy for Non-Muscle Invasive Bladder Cancer	Cancers
Bladder	Merten	2019	RCT+HT	369	Long-Term Experience of Chemoradiotherapy Combined with Deep Regional Hyperthermia for Organ Preservation in High-Risk Bladder Cancer	The Oncologist
Bladder	Datta	2019	CRT+HT	16	A Pilot Study of Radiotherapy and Local Hyperthermia in Elderly Patients With Muscle-Invasive Bladder Cancers Unfit for Definitive Surgery or Chemoradiotherapy	Front Oncol
Bladder	Inman	2014	CT+HT	15	A pilot clinical trial of intravesical mitomycin-C and external deep pelvic hyperthermia for non-muscle-invasive bladder cancer	Int J Hyperthermia
Bladder	Juang	2014	CT+HT	14	Thermal dosimetry characteristics of deep regional heating of non-muscle invasive bladder cancer	Int J Hyperthermia
Bladder	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
Bladder	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

Cervical

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Cervical	Kroesen	2019	RT+HT	400	The Effect of the Time Interval Between Radiation and Hyperthermia on Clinical Outcome in 400 Locally Advanced Cervical Carcinoma Patients	Front Oncol
Cervical	Franckena	2012	RT+HT	498	Review of radiotherapy and hyperthermia in primary cervical cancer	Int J Hyperthermia
Cervical	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.	Int J Hyperthermia
Cervical	Heijkoop	2012	RCT+HT	43	Neoadjuvant chemotherapy followed by radiotherapy and concurrent hyperthermia in patients with advanced-stage cervical cancer: a retrospective study	Int J Hyperthermia
Cervical	Van der Zee	2010	RCT+HT	6 studies	Combined use of hyperthermia and radiation therapy for treating locally advanced cervical carcinoma	Cochrane Database Syst Rev
Cervical	Franckena	2009	CDDP+HT	47	Weekly systemic cisplatin plus locoregional hyperthermia: An effective treatment for patients with recurrent cervical carcinoma in a previously irradiated area	Int J Hyperthermia
Cervical	Franckena	2009	RT+HT	420	Hyperthermia dose-effect relationship in 420 patients with cervical cancer treated with combined radiotherapy and hyperthermia	Eur J Cancer
Cervical	Franckena	2009	RT vs. RT+HT	378	Radiotherapy and hyperthermia for treatment of primary locally advanced cervix cancer: results in 378 patients	IJRO
Cervical	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
Cervical	Van der Zee	2006	RT+HT	114	Cervical cancer: Radiotherapy and hyperthermia	Int J Hyperthermia
Cervical	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
Cervical	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
Cervical	Jones	2003	RT+HT	12	A pilot Phase II trial of concurrent radiotherapy, chemotherapy, and hyperthermia for locally advanced cervical carcinoma.	Cancer
Cervical	Van der Zee	2001	RT vs. RT+HT	114	The Dutch Deep Hyperthermia Trial: results in cervical cancer	Int J Hyperthermia
Cervical	Van der Zee	2001	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
Cervical	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

Ovarian

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Ovarian	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	Int J Hyperthermia
Ovarian	Jones	2006	CT+HT	41	Intra-peritoneal cisplatin and whole abdomen hyperthermia for relapsed ovarian carcinoma	Int J Hyperthermia
Ovarian	Secord	2005	CT+HT	30	Phase I/II trial of intravenous Doxil and whole abdomen hyperthermia in patients with refractory ovarian cancer.	Int J Hyperthermia
Ovarian	Hahn	2004	CT+HT	32	Prospective assessment of quality of life in ovarian cancer patients receiving whole abdomen hyperthermia and liposomal doxorubicin.	Int J Hyperthermia

Pancreatic

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Pancreatic	Rogers	2021	CRT+HT	9	The addition of deep hyperthermia to gemcitabine-based chemoradiation may achieve enhanced survival in unresectable locally advanced adenocarcinoma of the pancreas	Clin Transl Radiat Oncol
Pancreatic	He	2019	CT+HT	17	Modified-FOLFIRINOX combined with deep regional hyperthermia in pancreatic cancer: a retrospective study in Chinese patients	Int J Hyperthermia
Pancreatic	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.	Int J Hyperthermia
Pancreatic	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

Pediatric

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Pediatric Sarcomas	Seifert	2016	CT+HT	10	Regional hyperthermia combined with chemotherapy in paediatric, adolescent and young adult patients: current and future perspectives	Radiat Oncol
Pediatric Germ Cell	Wessalowski	2014	HT	44	Regional deep hyperthermia for salvage treatment of children and adolescents with refractory or recurrent non-testicular malignant germ-cell tumours: an open-label, non-randomised, single-institution, phase 2 study.	Lancet Oncol
Pediatric Germ Cell	Wessalowski	2003	CT+HT	39	An approach for cure: PEI-chemotherapy and regional deep hyperthermia in children and adolescents with unresectable malignant tumors	Klin Padiatr
Germ Cell	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
Pediatric Germ Cell	Wessalowski	1998	CT+HT	10	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
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

Pelvic

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Vaginal	Aktas	2007	RT+HT	44	Concomitant radiotherapy and hyperthermia for primary carcinoma of the vagina: a cohort study.	Eur J Obstet
Pelvic	van der Zee	2000	RCT+HT	358	Comparison of radiotherapy alone with radiotherapy plus hyperthermia in locally advanced pelvic tumours: a prospective, randomised, multicentre trial	Lancet
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.	Int J Hyperthermia
Genitourinary	Petrovich	1991	RT vs. RT+HT	53	Regional hyperthermia in patients with recurrent genitourinary cancer.	Am J Clin Oncol

Prostate

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Prostate	Beck	2021	RT+HT	52	Salvage-Radiation Therapy and Regional Hyperthermia for Biochemically Recurrent Prostate Cancer after Radical Prostatectomy	Cancers
Prostate Protocol	Müller	2015	HT	#	Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial	Radiat Oncol
Prostate	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	Int J Hyperthermia
Prostate	Tilly	2005	RT+HT	22	Regional hyperthermia in conjunction with definitive radiotherapy against recurrent or locally advanced prostate cancer T3 pN0 M0.	Strahlenther Onkol
Prostate	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
Prostate	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
Prostate	Anscher	1997	RT+HT	30	Combined external beam irradiation and external regional hyperthermia for locally advanced adenocarcinoma of the prostate.	IJRO
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

Rectal

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Rectal	Ott	2021	CRT+HT	111	Neoadjuvant Chemoradiation Combined with Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer	Cancers
Rectal	Gani	2021	RCT+HT	78	Deep regional hyperthermia with preoperative radiochemotherapy in locally advanced rectal cancer, a prospective phase II trial	Radiother Oncol
Anal	Ott	2018	CRT+HT	112	Chemoradiotherapy with and without deep regional hyperthermia for squamous cell carcinoma of the anus	Strahlenther Onkol
Rectal	Zwirner	2017	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	Int J Hyperthermia
Rectal	Gani	2016	HT	103	Long-term local control and survival after preoperative radiochemotherapy in combination with deep regional hyperthermia in locally advanced rectal cancer	Int J Hyperthermia
Rectal	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.	Int J Hyperthermia
Rectal	Maluta	2010	RCT+HT	76	Regional hyperthermia added to intensified preoperative chemo-radiation in locally advanced adenocarcinoma of middle and lower rectum	Int J Hyperthermia
Rectal	Milani	2008	RCT+RHT	24	Radiochemotherapy in combination with regional hyperthermia in preirradiated patients with recurrent rectal cancer	Strahlenther Onkol
Rectal	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.	Int J Hyperthermia
Rectal	Juffermans	2003	RT+HT	54	Reirradiation and hyperthermia in rectal carcinoma: a retrospective study on palliative effect.	Cancer
Rectal	Schaffer	2003	RCT+HT	14	Feasibility and Morbidity of Combined Hyperthermia and Radiochemotherapy in Recurrent Rectal Cancer – Preliminary Results	Onkologie
Rectal	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
Rectal	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
Rectal	Rau	2000	RCT+HT	54	Preoperative radiochemotherapy in locally advanced or recurrent rectal cancer: regional radiofrequency hyperthermia correlates with clinical parameters.	IJRO
Rectal	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
Tumor	Rau	1998	RCT+HT	37	Preoperative Hyperthermia Combined with Radiochemotherapy in Locally Advanced Rectal Cancer - A Phase 11 Clinical Trial	Ann Surg

Sarcoma

Tumor	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
Soft Tissue Sarcoma	Lindner	2021	HT	#	Perioperative chemotherapy and regional hyperthermia for high-risk adult-type soft tissue sarcomas	Eur J Cancer
Soft Tissue Sarcoma	Issels	2021	CT+HT	109	Immune infiltrates in patients with localised high-risk soft tissue sarcoma treated with neoadjuvant chemotherapy without or with regional hyperthermia: A translational research program of the EORTC 62961-ESHO 95 randomised clinical trial	Eur J Cancer
Soft Tissue Sarcoma	Issels	2020	HT	109	Systemic antitumor effect by regional hyperthermia combined with low-dose chemotherapy and immunologic correlates in an adolescent patient with rhabdomyosarcoma – a case report	Int J Hyperthermia
Soft Tissue Sarcoma	Bücklein	2020	ICE+HT	110	Ifosfamide, Carboplatin, and Etoposide (ICE) in Combination with Regional Hyperthermia as Salvage Therapy in Patients with Locally Advanced Nonmetastatic and Metastatic Soft-Tissue Sarcoma	Sarcoma
Soft Tissue Sarcoma	Aklan	2019	HT	#	Regional deep hyperthermia: quantitative evaluation of predicted and direct measured temperature distributions in patients with high-risk extremity soft-tissue sarcoma	Int J Hyperthermia
Soft Tissue Sarcoma	Zschaeck	2018	CT+HT	61	Neoadjuvant chemotherapy plus radiation versus chemotherapy plus regional hyperthermia in high-grade soft tissue sarcomas: a retrospective comparison	Int J Hyperthermia
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
Soft Tissue Sarcoma	Eckert	2017	CT+HT	42	Radiotherapy and hyperthermia with curative intent in recurrent high risk soft tissue sarcomas	Int J Hyperthermia
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
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
Soft Tissue Sarcoma	Schlemmer	2010	RCT+HT	47	Thermochemotherapy in patients with extremity high-risk soft tissue sarcomas (HR-STS)	Int J Hyperthermia
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.	Int J Hyperthermia
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
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
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
Soft Tissue Sarcoma	Prosnitz	1999	RT+HT	97	The treatment of high-grade soft tissue sarcomas with preoperative thermoradiotherapy.	IJRO
Soft Tissue Sarcoma	Scully	1994	RT+HT	40	Clinical outcome after neoadjuvant thermoradiotherapy in high grade soft tissue sarcomas	J Surg Oncol
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

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

General / Technical

Subject	Author	Year	Method	No. of Patients	Title	Journal	Abstract Link
SWOT / TOWS	Datta	2020	HT	#	Integrating Loco-Regional Hyperthermia Into the Current Oncology Practice: SWOT and TOWS Analyses	Front Oncol
Guideline	Bruggmoser	2012	HT	#	Guideline for the clinical application, documentation and analysis of clinical studies for regional deep hyperthermia Quality management in regional deep hyperthermia	Strahlenther Onkol
Study Review	Sauer	2010	RT+HT	#	Concerning the final report “Hyperthermia: a systematic review” of the Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, March 2010	Strahlenther Onkol
Treatment Study	Puchinger	2009	HT	27	Psychological and systemic stress reactions of patients during hyperthermia treatments	Int J Hyperthermia
MRI Thermometry	Gellermann	2009	HT	#	Methods and potentials of magnetic resonance imaging for monitoring radiofrequency hyperthermia in a hybrid system	Int J Hyperthermia
Thermometry	Wust	2006	HT	#	Thermal monitoring: Invasive, minimal-invasive and non-invasive approaches	Int J Hyperthermia
Thermometry	van Rhoon	2005	HT	#	Introduction: Non-invasive thermometry for thermotherapy	Int J Hyperthermia
MRI Thermometry	Wust	2004	HT	33	Part-Body Hyperthermia with a Radiofrequency Multiantenna Applicator under Online Control in a 1.5 T MR-Tomograph	Rofo
Study Review	Hehr	2003	RCT+HT	#	Current and Potential Role of Thermoradiotherapy for Solid Tumours	Onkologie
Rationale	van de Zee	2002	HT	#	Heating the patient: a promising approach?	Ann Oncol
SAR	Tilly	2001	HT	#	Temperature data and specific absorption rates in pelvic tumours: predictive factors and correlations.	Int J Hyperthermia
Thermal Dose	Maguire	2001	HT	#	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	Int J Hyperthermia
Applicator Comparison	Feldmann	1993	HT	#	Deep regional hyperthermia: comparison between the annular phased array and the sigma-60 applicator in the same patients.	IJRO
Technical Study	Myerson	1991	HT	#	Phantom studies and preliminary clinical experience with the BSD 2000	Int J Hyperthermia

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