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 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.

Abstract: Concomitant radiotherapy and hyperthermia for primary carcinoma of the vagina: A cohort study

Objective

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

Study design

Cohort of 44 patients diagnosed with primary vaginal cancer between 1990 and 2002 was assessed. Survival rates and median survival of patients with primary vaginal cancer undergoing radiotherapy with and without hyperthermia were compared. Hyperthermia was solely added to radiotherapy in case of a tumor size >4 cm in diameter for FIGO stage III disease.

Results

The calculated overall 5-year survival of primary vaginal cancer was 63%. In comparison to histologic high grade tumors, higher survival rates for histologic low grade tumors were calculated. For FIGO stage III of disease, the addition of hyperthermia to radiotherapy for tumors >4 cm in diameter resulted similar survival rates and median survival when compared to those achieved by radiotherapy as monotherapy in tumors of <4 cm in diameter.

Conclusions

The addition of hyperthermia to radiotherapy might result in better survival rates in primary vaginal cancer for tumors >4 cm in diameter. The supplementary effect of hyperthermia to radiotherapy may be a feasible and beneficial approach in the treatment of vaginal cancer.

Authors

Aktas M, de Jong D, Nuyttens JJ, van der Zee J, Wielheesen DHM, Batman E, Burger CW, Ansink AC.

Study Link

Concomitant radiotherapy and hyperthermia for primary carcinoma of the vagina: A cohort study.
European Journal of Obstetrics & Gynecology and Reproductive Biology 2007;133(1):100-4.

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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.

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 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.

Abstract

BACKGROUND AND PURPOSE:

The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer.

MATERIALS AND METHODS:

After radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II-III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was administered for 45min before and during the HDR BT.

RESULTS:

The median follow-up time was 45months (range 3-72months). An effect of hyperthermia was not detected for disease-free survival (DFS) (log-rank test: p=0.178) or for local control (LC) (p=0.991). According to Cox's analysis, HT did not significantly influence failure or interactions with potential prognostic factors for LC or DFS. Statistical differences were not observed for the distribution of early and late complications between the HT and non HT groups.

CONCLUSIONS:

ISHT is well-tolerated and does not affect treatment-related early or late complications. Improvements in DFS and LC were not observed following the addition of ISHT to ISBT.

Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

STUDY LINK:

Radiother Oncol. 2013 Nov;109(2):194-9. doi: 10.1016/j.radonc.2013.04.011. Epub 2013 May 14.
Zolciak-Siwinska A¹, Piotrkowicz N, Jonska-Gmyrek J, Nicke-Psikuta M, Michalski W, Kawczyńska M, Bijok M, Bujko K.

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..

Phase I/II Cervical + Radiotherapy + Chemotherapy

Authors: Westermann A, Mella O, Van Der Zee J, Jones EL, Van Der Steen-Banasik E, Koper P, Uitterhoeve AL, De Wit R, Van Der Velden J, Burger C, Schem BC, Van Der Wilt C, Dahl O, Prosnitz LR, Van Tinteren H.
Publication: Int J Hyperthermia. 2012;28(6):549-53. doi: 10.3109/02656736.2012.673047. Epub 2012 Jul 13.

BACKGROUND:
Advanced cervical cancer is routinely treated with radiotherapy and cisplatin-containing chemotherapy. Hyperthermia has been shown to improve the results of both radiotherapy and cisplatin. The feasibility of the combination of all three modalities was demonstrated and reported in a study of 68 previously untreated cervical cancer patients in 2005. Long-term follow-up is presented here.

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 III Soft Tisse Sarcoma + Chemotherapy

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.

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).