Studien & Publikationen zur Hyperthermie
Forschung zur Hyperthermie
Forschung zur Hyperthermie
September 2012 – ongoing
A phase IIB study of the tetramodal therapy of T2-4NxM0 bladder cancer with hyperthermia combined with chemoradiotherapy following TUR-BT. (PI: Dr. B. Eberle / Dr. E. Puric, KSA).
End point
Primary: CR at end of treatment / Secondary: Functional bladder preservation, PFS and OS.
October 2013 – ongoing till 2018
A phase I/II study of concurrent hyperthermia and proton beam radiotherapy in primary and recurrent unresectable soft tissue sarcoma. (PI: Prof. N.R. Datta, KSA). ClinicalTrials.gov NCT01904565.
End point
Primary: Local tumour control, Acute and late morbidity, wound complication / Secondary: Local control rate at 2 years, LDFS at 2 years.
August 2016 – till 2021
A randomized phase II study of concurrent hyperthermia and chemoradiotherapy following neoadjuvant chemotherapy in locally advanced pancreatic cancers (HEATPAC). (PI: Prof. N.R. Datta, KSA). ClinicalTrials.gov NCT02439593.
End point
Primary: OS at 1 year, Acute and late morbidities / Secondary: Patterns of failure, PFS, DFS and OS.
June 2016 – ongoing
Phase I/II feasibility study with hyperthermia and proton beam radiotherapy in inoperable chordomas. Sponsors: PSI, KSA-KSB.
End point
Primary: Feasibility Secondary: Response rates, subjective improvement in symptoms.
July 2015 – July 2018
Trabactedin combined with regional hyperthermia as second line treatment for adult patients with advanced soft tissue sarcoma. Sponsors: Ludwig-Maximilians University of Munich, Klinikum Großhadern (Prof. R. Issels, Prof. Lars Linder). ClinicalTrials.gov NCT02359474.
End point
Primary: Progression free survival / Secondary: Overall survival.
March 2017 – Feb 2022
HyBT-H&N: Salvage brachytherapy with interstitial hyperthermia for locally recurrent head & neck carcinoma following previously external beam radiation therapy. Sponsors: University Klinik of Erlangen, Germany (Prof. V. Strnad, Prof. R. Fitkau).
End point
Primary: Loco-regional control (salvage) / Secondary: Acute and late morbidity.
Feb 2017 – Jan 2022
HyBla-RCT: Organ preservation treatment in bladder cancers with chemoradiotherapy vs thermochamoradiotherapy. Sponsors: University Klinik of Erlangen, Germany.
End point
Primary: Loco-regional control / Secondary: Bladder preservation, Relapse free survival (local and distant), acute and late toxicity.
Submitted for Ethical approval June 2017
HyZer_RCT_IBT: Multimodality therapy with chemoradiotherapy versus thermochemoradiotherapy and interstitial thermobrachytherapy.
End point
Primary: Overall survival / Secondary: Relapse free survival (local and distant), acute and late toxicity.
Jan 2015
Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer: A phase II study. Sponsors: Charité, University Klinik Berlin, University Klinik of Tübingen (Dr. P. Ghajar).
End point
Primary: Acute GU toxicity.
May 2015 – ongoing
Prostate BT-HT: A prospective phase II study of salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy. Sponsors: M.Sklodowskiej-Curie, Krakow, Poland and University Klinik of Erlangen (Dr.A. Kukielka, Dr. V. Strnad).
End point
Primary: Loco-regional control / Secondary: acute and late toxicity.
Sept 2013 – ongoing
A randomized two-armed open study on the adjuvant therapy in patients with R0/R1 resected pancreatic carcinoma with Gemcitabine plus Capecitabine (Arm GC) vs. Gemcitabine plus Cisplatin with regional hyperthermia (Arm GPH). Sponsors: Klinikum Grosshadern, Medical Center, University of Munich (Dr. K. Lechner, Prof. L. Linder, Prof. R. Issels). HEAT-Study EudraCT-Nr.: 2008-004802-14. ClinicalTrials.gov NCT01077427.
End point
Primary: Disease free survival / Secondary: Overall survival, acute and late toxicity.
March 2011 – ongoing
Neoadjuvant chemoradiation with 5-FU and Oxaliplatin combined with deep regional hyperthermia in locally recurrent rectal cancer. A multi-institutional Phase I/II Study (HyRec Trial). Sponsors: University Klinik of Erlangen, Germany (Prof. O.Ott, Prof. R. Fietkau). HyRec Trial Strahlenklinik 2009-010093-38. ClinicalTrials.gov NCT01716949.
End point
Primary: Feasibility rate / Secondary: Local progression-free survival, Distant metastasis-free survival (excluding M1 patients), Overall survival (excluding M1 patients), Response rate (RECIST criteria), Rate of curative resections (R0), Rate of acute and late toxicity.
Dec 2014 – April 2021
Phase 2 Randomized Trial to evaluate effects of deep regional hyperthermia in patients with anal carcinoma treated by standard radiochemotherapy (Hycan). Sponsors: University of Erlangen-Nürnberg Medical School (Dr. G. Grabenbauer). ClinicalTrials.gov NCT02369939.
End point
Primary: Improvement of complete remission / Secondary: Colostomy-free survival, Locoregional relapse-free survival , Overall relapse-free survival, Overall survival, Response rate, Acute and late toxicity, Quality of life.
Presently not active
Prospective randomized phase III trial comparing postsurgical radiotherapy alone versus adjuvant radiotherapy plus hyperthermia in patients with localized prostate cancer. Sponsors: Akademisches Lehrkrankenhaus Radiologie- Zentrum of Fulda, Germany, Univ Hospital Verona, Italy (Dr. H.J. Feldmann, Prof. S. Maluta).
End point
Primary: Freedom from progression / Secondary: local-regional progression, distant metastases, disease-free survival, prostate cancer specific survival, nonprostate cancer specific survival, overall survival, and time to biochemical (PSA) failure, acute and late toxicity.
Details NA
Chemoradiation plus hyperthermia in muscle invasive bladder cancer: A phase II trial. (PI: M. Hulshof, Amsterdam).
End point
Details : NA.
June 2018 – April 2024
Organ preservation in locally advanced rectal cancer by radiochemotherapy followed by consolidation chemotherapy (CAO/ARO/AIO-16). Sponsors / Collaborators: University Hospital Tübingen, Germany. ClinicalTrials.gov NCT03561142.
End point
Primary: Clinical complete response / Secondary: Local regrowth rate, safety, faecal incontinence, QOL, surgical interventions, surgical morbidity, pathological staging, R0 rate, Rate of sphincter sparing surgery, relapse free survival, overall survival.
Recruiting
Modulated Electro-Hyperthermia plus Chemo-radiation for locally Advanced Cervical Cancer patients in South Africa. Interventions – Device: Modulated electro-hyperthermia / Radiation: External beam radiation / Drug: Cisplatin / Radiation: Brachytherapy.
Locations
Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, Gauteng, South Africa.
Active, not recruiting
The Effect of Electro-Hyperthermia in Preoperative Radiotherapy for Locally Advanced Rectal Cancer. Interventions – Device: Electrohyperthermia.
Locations
Wonju Severance Christian Hospital, Wonju, Gangwon, Korea, Republic of.
Recruiting
Neoadjuvant Chemoradiation with 5-FU(or Capecitabine) and Oxaliplatin Combined with Hyperthermia in Rectal Cancer. Interventions – Radiation: Radiotherapy / Procedure: Hyperthermia / Drug: 5-Fluorouracil / Drug: Capecitabine / Drug: Oxaliplatin.
Locations
Klinik Bad Trissl, Innere Medizin, Bad Trissl, Germany / University Hospital, Duesseldorf, Germany / Universitätsklinikum Erlangen, Strahlenklinik, Erlangen, Germany / LMU München, Campus Großhadern, Medizinische Klinik III, Hyperthermie, München, Germany / Schlossbergklinik, Oberstaufen, Germany / Universitätsklinikum Tübingen, Radioonkologie, Tübingen, Germany.
Terminated
Efficacy of NeoThermo-Radiochemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial. Interventions – Radiation: Hyperthermia with concurrent chemo-radiation therapy.
Locations
Samsung Medical Center, Seoul, Korea, Republic of.
Completed
Preoperative Radiochemotherapy with Hyperthermia for locally advanced Rectal Cancer. Interventions – Hyperthermia / Hyperthermic Radiochemotherapy / Hyperthermic Chemoradiotherapy / Deep Regional Hyperthermia / Other: Deep regional hyperthermia / Radiation: Radiotherapy / Drug: Chemotherapy (5-Fluorouracil).
Locations
University Hospital Tübingen, Department of Radiation Oncology, Tübingen, Baden-Württemberg, Germany.
Recruiting
Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy. Interventions – Radiation: Radiotherapy / Drug: Chemotherapy / Other: Deep regional hyperthermia.
Locations
University Hospital Erlangen, Erlangen, Germany / University Hospital Frankfurt, Frankfurt, Germany / University Hospital Tübingen, Tübingen, Germany / University Hospital Würzburg, Würzburg, Germany.
Ongoing
Hyperthermia and Proton Therapy in Unresectable Soft Tissue Sarcoma. Interventions – Radiation: Hyperthermia and Proton Beam.
Locations
Kantonsspital Aarau, Aarau, Aargau, Switzerland / PSI, Viilligef / Univ Hosp Zurich /Balgrist Clinic, Zurich.
Completed
Combination Chemotherapy with or without Hyperthermia Therapy in Treating Patients with Soft Tissue Sarcoma. Interventions – Drug: doxorubicin hydrochloride / Drug: etoposide / Drug: ifosfamide / Procedure: conventional surgery / Procedure: hyperthermia treatment / Radiation: radiation therapy.
Locations
Robert Roessle Comprehensive Cancer Center at University of Berlin – Charite Campus Buch, Berlin, Germany / Universitaetsklinikum Essen, Essen, Germany / Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany / Klinikum der Universitaet Muenchen – Grosshadern Campus, Munich, Germany.
Recruiting
Preoperative Hypofractionated Radiotherapy with Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas. Interventions – Radiation: Hypofractionated radiotherapy / Other: Hyperthermia.
Locations
Maria Sklodowska-Curie Institute – Oncology Center, Warsaw, Mazovian, Poland.
Recruiting
Hyper-Thermia Enhanced Antitumor Efficacy of Trabectedin. Interventions – Drug: Trabectedin / Genetic: DNA doublestrand breaks / Hyperthermia.
Locations
Ludwig-Maximilians University of Munich, Klinikum Großhadern, Munich, Bavaria, Germany / Helios Klinikum Bad Saarow, Bad Saarow, Germany / Charité – Universitätsmedizin Berlin, Berlin, Germany / Helios Klinikum BerlinBuch, Berlin, Germany / Universitätsklinikum Erlangen, Erlangen, Germany.
Unknown status
Hyperthermia with Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer. Interventions – Device: Heckel Infrared Radiant Heat Device / Other: cisplatin, gemcitabine, interferonalpha / Other: thermochemotherapy.
Locations
Memorial Hermann Hospital, Houston, Texas, United States.
Unknown status
Multicenter RCT of the Clinical Effectiveness of Oncothermia with Chemotherapy in Metastatic Pancreatic Cancer Patients. Interventions – Other: Oncothermia / Drug: FOLFIRINOX or Gemcitabine based chemotherapy.
Locations
Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea, Republic of.
Recruiting
Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study. Interventions – Other: Chemoradiotherapy (CTRT) / Other: Thermochemoradiotherapy (CTRTHT).
Locations
Kantonsspital Aarau, Aarau, Aargau, Switzerland.
Unknown status
Comparing the Effectiveness of Combined Hyperthermia and External Beam Radiation (EBRT) Versus EBRT Alone in Treating Patients with Painful Bone Metastases. Interventions – Other: Hyperthermia / Radiation: External-beam radiotherapy.
Locations
Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
Current indications of deep hyperthermia at Kantonsspital Aarau with levels of evidence for each site and the related key citations
Contributions by KSA to promote hyperthermia in National and International scientific forums (2018 -2019)