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 II Prostate + Radiotherapy

Authors: Anscher MS, Samulski TV, Dodge R, Prosnitz LR, Dewhirst MW.
Publication: Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):1059-65.

PURPOSE:
To determine the safety and efficacy of combined external beam irradiation and external regional hyperthermia in the treatment of adenocarcinoma of the prostate.

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 II Pancreatic + Chemotherapy

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.

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 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..

Phase II Reccurent Rectal + Chemotherapy

Authors: Gellermann J, Wlodarczyk W, Feussner A, Fähling H, Nadobny J, Hildebrandt B, Felix R, Wust P.
Publication: Int J Hyperthermia. 2005 Sep;21(6):497-513.

INTRODUCTIONS:
Non-invasive thermometry (NIT) is a valuable and probably indispensable tool for further development of radiofrequency (RF) hyperthermia. A hybridization of an MRI scanner with a hyperthermia system is necessary for a real-time NIT. The selection of the best thermographic method is difficult, because many parameters and attributes have to be considered.

Phase II Soft Tissue Sarcoma + Chemotherapy

Authors: Issels RD, Abdel-Rahman S, Wendtner C, Falk MH, Kurze V, Sauer H, Aydemir U, Hiddemann W.
Publication: Eur J Cancer. 2001 Sep;37(13):1599-608.

PURPOSE:
In this phase II study, activity and safety of neoadjuvant regional hyperthermia (RHT) combined with chemotherapy was investigated in 59 patients with primary advanced or recurrent high-risk soft-tissue sarcoma (STS).

Phase II Rectal + Radiotherapy + Chemotherapy

Authors: M Romano, S Maluta, C Cordiano, G.G Delaini, M Genna, C Oliani, P Capelli, A Tomezzolli, C Manfrini, A.B Porcaro, M Gabbani, G Chierego
Publication: International Journal of Radiation Oncology, October 1, 2003Volume 57, Issue 2, Supplement, Pages S386–S387

PURPOSE:
To evaluate toxicity and pathological complete response rate in treating preoperatively rectal cancer patients by radiation dose escalation combined with RH + CT.

Phase II Rectal + Radiotherapy + Chemotherapy

Authors: Rau B, Wust P, Hohenberger P, Löffel J, Hünerbein M, Below C, Gellermann J, Speidel A, Vogl T, Riess H, Felix R, Schlag PM.
Publication: Ann Surg. 1998 Mar;227(3):380-9. Review.

OBJECTIVE:
A prospective phase II study was performed to determine the feasibility and efficacy in terms of response rate, resectability, and morbidity in patients with locally advanced rectal cancer who received preoperative regional hyperthermia combined with radiochemotherapy (HRCT).

Phase II Rectal + Radiotherapy + Chemotherapy

Authors: Rau B, Wust P, Tilly W, Gellermann J, Harder C, Riess H, Budach V, Felix R, Schlag PM.
Publication: Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):381-91.

PURPOSE:
Preoperative radiochemotherapy (RCT) is a widely used means of treatment for patients suffering from primary, locally advanced, or recurrent rectal cancer. We evaluated the efficacy of treatment due to additional application of regional hyperthermia (HRCT) to this conventional therapy regime in a Phase II study, employing the annular phased-array system BSD-2000 (SIGMA-60 applicator). The clinical results of the trial were encouraging. We investigated the relationship between a variety of thermal and clinical parameters in order to assess the adequacy of thermometry, the effectiveness of hyperthermia therapy, and its potential contribution to clinical endpoints.

Phase II Bladder + Radiotherapy + Chemotherapy

Authors: Wittlinger M, Rödel CM, Weiss C, Krause SF, Kühn R, Fietkau R, Sauer R, Ott OJ.
Publication: Radiother Oncol. 2009 Nov;93(2):358-63. doi: 10.1016/j.radonc.2009.09.018.

PURPOSE:
To assess the safety and effectiveness of treating high-risk T1 and T2 bladder cancer with transurethral resection (TUR-BT) followed by radiochemotherapy (RCT) combined with regional deep hyperthermia (RHT).

Phase II Rectal + Radiohemotherapy

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.

Phase II Rectal + Radiotherapy + Chemotherapy

Authors: Maluta S, Romano M, Dall'oglio S, Genna M, Oliani C, Pioli F, Gabbani M, Marciai N, Palazzi M.
Publication: Int J Hyperthermia. 2010;26(2):108-17. doi: 10.3109/02656730903333958.

PURPOSE:
To evaluate the safety of delivering pre-operative regional hyperthermia (HT) plus an intensified chemo-radiotherapy (CRT) regimen in patients suffering from locally advanced rectal cancer.

Phase II Genitourinary + Chemotherapy

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%).