Phase I/II Cervical + Chemotherapy

Authors: de Wit R, van der Zee J, van der Burg ME, Kruit WH, Logmans A, van Rhoon GC, Verweij J.
Publication: Br J Cancer. 1999 Jul;80(9):1387-91.

ABSTRACT:
We investigated the feasibility and the anti-tumour activity of weekly cisplatin and the simultaneous application of local hyperthermia in patients with a pelvic recurrence of cervical cancer in previously irradiated area. Dose levels of cisplatin 60 mg m(-2), 70 mg m(-2) and 80 mg m(-2) were studied.

Phase I/II Deep Tumor + Radiotherapy

Authors: Myerson RJ, Scott CB, Emami B, Sapozink MD, Samulski TV.
Publication: Int J Hyperthermia. 1996 Jul-Aug;12(4):449-59.

PURPOSE:
The purpose of this paper is to evaluate the safety and efficacy of deep hyperthermia in conjunction with radiation therapy.

Phase II Soft Tissue Sarcoma + Radiotherapy

Authors: Maguire PD, Samulski TV, Prosnitz LR, Jones EL, Rosner GL, Powers B, Layfield LW, Brizel DM, Scully SP, Harrelson JM, Dewhirst MW.
Publication: Int J Hyperthermia. 2001 Jul-Aug;17(4):283-90.

PURPOSE:
We prospectively evaluated whether delivering a thermal dose of > 10 cumulative equivalent minutes at 43 degrees C to >90% of the tumour sites monitored (CEM43 degrees T90) would produce a pathologic complete response (pCR) in > 75% of high-grade soft tissue sarcomas treated pre-operatively with thermoradiotherapy.

Phase II Cervical + Radiotherapy + Chemotherapy

Authors: Jones EL, Samulski TV, Dewhirst MW, Alvarez-Secord A, Berchuck A, Clarke-Pearson D, Havrilesky LJ, Soper J, Prosnitz LR.
Publication: Cancer. 2003 Jul 15;98(2):277-82.

BACKGROUND:
Five randomized studies have demonstrated a benefit derived from adding cisplatin (CDDP)-based chemotherapy to radiotherapy (RT) for treatment of cervical carcinoma. The Dutch Phase III pelvic tumor trial demonstrated a survival and local control benefit due to the addition of hyperthermia (HT) to RT. The authors evaluated response and toxicity in patients with locally advanced cervical carcinoma (LACC) who were treated with concurrent weekly CDDP, HT, and RT (whole pelvis [n=7] and whole pelvis and paraaortic nodes [n=5]).

Phase II Rectal + Radiotherapy + Chemotherapy

Authors: Anscher MS, Lee C, Hurwitz H, Tyler D, Prosnitz LR, Jowell P, Rosner G, Samulski T, Dewhirst MW.
Publication: Int J Radiat Oncol Biol Phys. 2000 Jun 1;47(3):719-24.

PURPOSE:
To determine the feasibility of combining external beam radiotherapy, continuous infusion 5-fluorouracil (5-FU), and external microwave hyperthermia in patients with locally advanced, unresectable, or recurrent adenocarcinoma of the rectum.

Phase II Pediatric Germ Cell + Chemotherapy

Authors: Wessalowski R, Schneider DT, Mils O, Hannen M, Calaminus G, Engelbrecht V, Pape H, Willers R, Engert J, Harms D, Göbel U.
Publication: Klin Padiatr. 2003 Nov-Dec;215(6):303-9.

BACKGROUND:
Elevated temperatures of 40 - 44 degrees C increase the actions of various anticancer drugs including N-lost derivatives, cytotoxic antibiotics and platinum analoga. In clinical usage thermochemotherapy (TCH) should facilitate surgical resection and ameliorate local tumor control.

Phase I/II Soft Tissue Sarcoma + Radiotherapy

Authors: Scully SP, Oleson JR, Leopold KA, Samulski TV, Dodge R, Harrelson JM.
Publication: J Surg Oncol. 1994 Nov;57(3):143-51.

PURPOSE:
In the treatment of soft tissue sarcomas, hyperthermia has been demonstrated to enhance tumor necrosis from radiation therapy. The current study reports the clinical course of patients treated with this neoadjuvant therapy regimen.

Phase III Bladder/Cervical/Rectal + Radiotherapy

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.

Phase II Vaginal + Radiotherapy

Authors: Aktas M, de Jong D, Nuyttens JJ, van der Zee J, Wielheesen DH, Batman E, Burger CW, Ansink AC.
Publication: Eur J Obstet Gynecol Reprod Biol. 2007 Jul;133(1):100-4. Epub 2006 Jun 13.

OBJECTIVE:
To evaluate the supplementary value of adding hyperthermia to radiotherapy in patients with primary vaginal cancer.

Phase II Prostate + Radiotherapy + Androgen Suppression Therapy

Authors: Maluta S, Dall'Oglio S, Romano M, Marciai N, Pioli F, Giri MG, Benecchi PL, Comunale L, Porcaro AB
Publication: Int J Hyperthermia. 2007 Aug;23(5):451-6.

PURPOSE:
Hyperthermia has been used in several trials to treat pelvic cancers without excessive toxicity and with positive results. The aim of this study was to evaluate feasibility and results in terms of biochemical recurrence-free, disease-free survival, overall survival, and treatment toxicity profile of hyperthermia combined with radiotherapy in locally advanced high risk prostate cancer.

Phase II Pelvic + Radiotherapy

Authors: Feldmann HJ, Molls M, Krümplemann S, Stuschke M, Sack H.
Publication: Int J Radiat Oncol Biol Phys. 1993 Apr 30;26(1):111-6.

PURPOSE:
Several institutions have accumulated clinical experience with the annular array as well as with the Sigma applicator. There exist only limited data in comparison of both heating devices possibly favoring the annular array over the Sigma applicator with regard to tumor temperatures and acute toxicity. The objective of this study was to record temperature distributions at identical sites in tumor and normal tissue in the same patients treated with each device.

Phase III Soft Tissue Sarcoma + Chemotherapy

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.

Phase III Soft Tissue Sarcoma + Chemotherapy

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.

Analysis Rectal + Radiotherapy + Chemotherapy

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.

Introduction to Pyrexar Family of Hyperthermia systems. 2 page full color.  Original available upon request for translation.

Phase I/II Cervical + Radiotherapy + Chemotherapy

Authors: Westermann AM, Jones EL, Schem BC, van der Steen-Banasik EM, Koper P, Mella O, Uitterhoeve AL, de Wit R, van der Velden J, Burger C, van der Wilt CL, Dahl O, Prosnitz LR, van der Zee J.
Publication: Cancer. 2005 Aug 15;104(4):763-70.

BACKGROUND:
Patients with advanced cervical carcinoma are treated routinely with radiotherapy and cisplatin-containing chemotherapy. It has been shown that hyperthermia can improve the results of both radiotherapy and cisplatin. In the current study, the feasibility and efficacy of the combination of all three modalities was studied in previously untreated patients with cervical carcinoma.

Phase I/II Pediatric Germ Cell + Chemotherapy

Authors: Wessalowski R, Kruck H, Pape H, Kahn T, Willers R, Göbel U.
Publication: Cancer. 1998 Feb 15;82(4):793-800.

PURPOSE:
Extracranial nontesticular germ cell tumors (GCTs) are rare malignancies in children and adolescents. Cisplatin-containing regimens and complete tumor resection are important determinants for a favorable outcome; however, patients with recurrent tumors that cannot be eradicated by surgical procedures and chemotherapy have a poor prognosis. Noninvasive electromagnetic technologies for superficial and regional deep hyperthermia (RHT) are under investigation to enhance local tumor control in various malignancies. The objectives of this Phase I/II study were to examine 1) whether RHT can be used in combination with platinum-based chemotherapy with acceptable toxicity in children and adolescents and 2) whether this combined regimen can induce objective tumor response in patients with malignant nontesticular GCT that persisted or recurred locoregionally after validated, intensive, cisplatin-based chemotherapy +/- surgery as unsuccessful first-line treatment.

Phase II Soft Tissue Sarcoma + Chemotherapy

Authors: Issels RD1, Prenninger SW, Nagele A, Boehm E, Sauer H, Jauch KW, Denecke H, Berger H, Peter K, Wilmanns W.
Publication: J Clin Oncol. 1990 Nov;8(11):1818-29.

PURPOSE:
From July 1986 to July 1989, 40 patients (92% pretreated) with deep-seated, advanced soft tissue sarcomas (STS, 25 patients), Ewing's sarcomas (ES, eight patients), osteosarcomas (OS, three patients) and chondrosarcomas (ChS, four patients) were treated at the University of Munich in a protocol involving regional hyperthermia (RHT) combined with ifosfamide plus etoposide.

Phase I/II Soft Tissue Sarcoma + Chemotherapy

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.

Phase II Ovarian + Chemotherapy

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..