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Quality assurance for clinical studies in regional deep hyperthermia

Qualitätssicherung in der regionalen Tiefenhyperthermie

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Background

A guideline is provided for the implementation of regional deep hyperthermia treatments under strict rules of quality assurance. The objective is to guarantee a comparable and comprehensible method in the treatment and scientific analysis of hyperthermia. The guideline describes regional deep hyperthermia (RHT) and MR-controlled partial body hyperthermia (PBH) of children, young and adult patients. According to this guideline, hyperthermia treatment is always applied in combination with chemotherapy and/or radiotherapy.

Methods

The guideline is based on practical experience from several hyperthermia centers. The procedure allows applying jointly coordinated standards and quality control in hyperthermia for studies.

Results

The guideline contains recommendations for hyperthermia treatments, including indication, preparation, treatment, and standardized analysis.

Hintergrund

Zur Durchführung von qualitätsgesicherten Tiefenhyperthermiebehandlungen wurde eine Leitlinie erstellt. Ziel war, ein vergleichbares und nachvollziehbares Vorgehen bei der Behandlung und der wissenschaftlichen Auswertung von Hyperthermiebehandlungen zu gewährleisten. Die Leitlinie beschreibt die „Regionale Tiefenhyperthermie“ (RHT) und die „MR-kontrollierte Teilkörperhyperthermie“ (PBH) von Kindern, jugendlichen und erwachsenen Patienten. Hyperthermie im Sinne der Leitlinie wird als Kombinationsbehandlung mit einer Chemo- und/oder Strahlentherapie durchgeführt.

Methodik

Die Leitlinie basiert auf praktischen Erfahrungen mehrerer Hyperthermiezentren. Dieses Vorgehens erlaubt abgestimmte Standards in der Anwendung und der Qualitätskontrolle in der Hyperthermie für Studien.

Ergebnisse

Diese Leitlinie enthält Empfehlungen für Hyperthermiebehandlungen mit Indikationsstellung, Vorbereitung, Durchführung und standardisierter Auswertung.

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References

  1. Bruggmoser G, Bauchowitz S, Canters R et al. Leitlinien für die klinische Applikation, die Dokumentation und die Analyse klinischer Studien bei der regionalen Tiefenhyperthermie. Strahlenther Onkol 2011, to be published.

  2. de Bruijne M, van der Holt B, van Rhoon GC et al. Evaluation of CEM43 degrees CT90 thermal dose in superficial hyperthermia: a retrospective analysis. Strahlenther Onkol 2010;186:436–43.

    Article  PubMed  Google Scholar 

  3. Canters RA, Franckena M, Paulides MM et al. Patient positioning in deep hyperthermia: influences of inaccuracies, signal correction possibilities and optimization potential. Phys Med Biol 2009;54:3923–36.

    Article  PubMed  CAS  Google Scholar 

  4. Canters RA, Wust P, Bakker JF et al. A literature survey on indicators for characterisation and optimisation of SAR distributions in deep hyperthermia, a plea for standardisation. Int J Hyperthermia 2009;25:593–608.

    Article  PubMed  CAS  Google Scholar 

  5. Crezee J, van Haaren PM, Westendorp H et al. Improving locoregional hyperthermia delivery using the 3-D controlled AMC-8 phased array hyperthermia system: a preclinical study. Int J Hyperthermia 2009;25:581–92.

    Article  PubMed  CAS  Google Scholar 

  6. Eckert F, Fehm T, Bamberg M et al. Small cell carcinoma of vulva: curative multimodal treatment in face of resistance to initial standard chemotherapy. Strahlenther Onkol 2010:186:521–4.

    Article  PubMed  Google Scholar 

  7. Fatehi D, de Bruijne M, van der Zee J et al. RHyThM, a tool for analysis of PDOS formatted hyperthermia treatment data generated by the BSD2000/3D system. Int J Hyperthermia 2006;22:173–84.

    Article  PubMed  Google Scholar 

  8. Fatehi D, van der Zee J, Notenboom A et al. Comparison of intratumor and intraluminal temperatures during locoregional deep hyperthermia of pelvic tumors. Strahlenther Onkol 2007;183:479–86.

    Article  PubMed  Google Scholar 

  9. Franckena M, Fatehi D, de Bruijne M et al. Hyperthermia dose-effect relationship in 420 patients with cervical cancer treated with combined radiotherapy and hyperthermia. Eur J Cancer 2009;45:1969–78.

    Article  PubMed  Google Scholar 

  10. Gellermann J, Wlodarczyk W, Feussner A et al. Methods and potentials of magnetic resonance imaging for monitoring radiofrequency hyperthermia in a hybrid system. Int J Hyperthermia 2005;21:497–513.

    Article  PubMed  CAS  Google Scholar 

  11. Gellermann J, Wlodarczyk W, Hildebrandt B et al. Noninvasive magnetic resonance thermography of recurrent rectal carcinoma in a 1.5 Tesla hybrid system. Cancer Res 2005;65:5872–80.

    Article  PubMed  CAS  Google Scholar 

  12. Gellermann J, Hildebrandt B, Issels R et al. Noninvasive magnetic resonance thermography of soft tissue sarcomas during regional hyperthermia: correlation with response and direct thermometry. Cancer 2006;107:1373–82.

    Article  PubMed  Google Scholar 

  13. Haveman J, Smals OA, Rodermond HM. Effects of hyperthermia on the rat bladder: a pre-clinical study on thermometry and functional damage after treatment. Int J Hyperthermia 2003;19:45–57.

    Article  PubMed  CAS  Google Scholar 

  14. Hoffmann K-T, Rau B, Wust P et al. Restaging of locally advanced carcinoma of the rectum with MR imaging after preoperative radio-chemotherapy plus regional hyperthermia. Strahlenther Onkol 2002;178:386–92.

    Article  PubMed  Google Scholar 

  15. Hua Y, Ma S, Fu Z et al. Intracavity hyperthermia in nasopharyngeal cancer: a phase III clinical study. Int J Hyperthermia 2011;27:180–6.

    Article  PubMed  Google Scholar 

  16. Issels RD. Hyperthermia adds to chemotherapy. Eur J Cancer 2008;44:2546–54.

    Article  PubMed  CAS  Google Scholar 

  17. Issels RD, Lindner LH, Verweij J et al., for the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group (EORTC-STBSG) and the European Society for Hyperthermic Oncology (ESHO). Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study. Lancet Oncol 2010;11:561–70.

    Article  PubMed  CAS  Google Scholar 

  18. Konstanczak R, Wust P, Sander B et al. Thermometrie durch Messung der chemischen Verschiebung eines Lanthanidenkomplexes, Strahlenther Onkol 1997;173:106–16.

    Article  PubMed  CAS  Google Scholar 

  19. Lagendijk JJW, van Rhoon GC, Hornsleth SN et al. ESHO quality assurance guidelines for regional hyperthermia. Int J Hyperthermia 1998;14:125–33.

    Article  PubMed  CAS  Google Scholar 

  20. Lee ER, Sullivan DM, Kapp DS. Potential hazards of radiative electromagnetic hyperthermia in the presence of multiple metallic surgical clips. Int J Hyperthermia 1992;8:809–17.

    Article  PubMed  CAS  Google Scholar 

  21. De Leeuw AAC, Crezee J, Lagendijk JJW. Temperature and SAR measurements in deep-body hyperthermia with thermocouple thermometry. Int J Hyperthermia 1993;:685–97.

    Article  Google Scholar 

  22. Lutgens L, van der Zee J, Pijls-Johannesma M et al. Combined use of hyperthermia and radiation therapy for treating locally advanced cervical carcinoma. Cochrane Gynaecological Cancer Group ed, The Cochrane Collaboration, Published by John Wiley & Sons, Ltd. Issue1, 2010. (http://www.thecochranelibrary.com).

  23. Mantel F, Frey B, Haslinger S et al. Combination of ionising irradiation and hyperthermia activates programmed apoptotic and necrotic cell death pathways in human colorectal carcinoma cells. Strahlenther Onkol 2010;186:587–99.

    Article  PubMed  Google Scholar 

  24. Milani V, Pazos M, Issels RD et al. Radiochemotherapy in combination with regional hyperthermia in preirradiated patients with recurrent rectal cancer. Strahlenther Onkol 2008;184:163–8.

    Article  PubMed  Google Scholar 

  25. Ott O, Belka C, Issels R et al. Neoadjuvant chemoradiation with 5-FU (or capecitabine) and oxaliplatin combined with deep regional hyperthermia in locally recurrent rectal cancer (HyRec Trial). Strahlenther Onkol 2010;186(Suppl 1):49.

    Google Scholar 

  26. Pyatykh S, Zheng L, Wehner C et al. MRI artefact correction for (hyperthermia) treatment planning, Strahlenther Onkol 2010;186(Suppl 1):51.

    Google Scholar 

  27. Rau B, Wust P, Gellermann J et al. Phase-II-Studie zur pr operativen Radio-Chemo-Thermo-Therapie beim lokal fortgeschrittenen Rektum-Karzinom. Strahlenther Onkol 1998;174:556–65.

    Article  PubMed  CAS  Google Scholar 

  28. Tilly W, Gellermann J, Graf R et al. Regional hyperthermia in conjunction with definitive radiotherapy against recurrent or locally advanced prostate cancer T3 pN0 M0. Strahlenther Onkol 2005;181:35–41.

    Article  PubMed  Google Scholar 

  29. van der Wal E, Frankena M, Wielheesen DHM et al. Steering in locoregional deep hyperthermia: evaluation of common practice with 3D-planning. Int J Hyperthermia 2008;24:682–93.

    Article  PubMed  Google Scholar 

  30. Van der Zee J, Gonzalez Gonzalez D, Van Rhoon GC et al. Comparison of radiotherapy alone with radiotherapy plus hyperthermia in locally advanced pelvic tumours: a prospective, randomised, multicentre trial. Dutch Deep Hyperthermia Group. Lancet 2000; 1;355(9210):1119–25.

    Google Scholar 

  31. Van der Zee J. Heating the patient: a promising approach? Ann Oncol 2002;13:1173–84.

    Article  PubMed  Google Scholar 

  32. Wust P, Gellermann J, Harder C. Rationale for using invasive thermometry for regional hyperthermia of pelvic tumors. Int J Radiation Oncology Biol Phys 1998;41:1129–37.

    Article  CAS  Google Scholar 

  33. Yarmolenko PS, Moon EJ, Landon C et al. Thresholds for thermal damage to normal tissues: an update. Int J Hyperthermia. 2011;27:320–43.

    Article  PubMed  Google Scholar 

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Correspondence to Gregor Bruggmoser.

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*The authors of this document are also members of the ESHO Technical Committee.

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Bruggmoser, G., Bauchowitz, S., Canters, R. et al. Quality assurance for clinical studies in regional deep hyperthermia. Strahlenther Onkol 187, 605–610 (2011). https://doi.org/10.1007/s00066-011-1145-x

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  • DOI: https://doi.org/10.1007/s00066-011-1145-x

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