Wissen schafft Heilung.

  Klinik und Poliklinik
  für RadioOnkologie
  und Strahlentherapie

  Klinikleitung
  Univ.-Prof. Dr. med.
  Stephanie E. Combs

  Klinikum rechts der Isar
  Technische Universität München
  Ismaninger Str. 22
  D - 81675 München
  direktion.radonk@mri.tum.de

  Direktionssekretariat
  Tel.: + 49 89 4140 - 4501 / - 4502


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  Terminvereinbarung:

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  Tel.: + 49 89 4140 - 4511
  privatambulanz.radonk@mri.tum.de

  Allgemeine Ambulanz im
  Tumortherapiezentrum (TTZ)

  Tel.: + 49 89 4140 - 4510
  ambulanz.radonk@mri.tum.de

  Spezialambulanz Stereotaxie,
  Brachytherapie

  Tel.: + 49 89 4140 - 4509

  Station R2a
 
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STRASS

A phase III randomized study of preoperative radiotherapy plus surgery versus surgery alone for patients with Retroperitoneal sarcoma (RPS)

Retroperitoneal sarcomas are cancers which grow inside the abdomen (the part of the body between the chest and the pelvis) but are not directly associated with specific organs. They are often painless until they become large and they can be difficult to diagnose. Specialist surgery is required to remove them safely and this surgery can be a cure without any further treatment. Surgery for retroperitoneal sarcoma is a big operation and requires careful planning. The tumours themselves can be large and their safe removal can mean that organs in the body (such as the spleen) need to be removed as well. The surgeon’s aim is to remove all signs of the cancer, this is the surest way of preventing the cancer from coming back. For quite a long time there has been discussion about treating the tumour with radiotherapy before surgery, hoping that this might have a benefit for the patient by reducing the risk of the tumour coming back in the future. There is very little research published on this topic and the number of cases where it has been tried is small, although these reports are generally positive. At this moment there is no reliable answer to the question. This study’s objective is to provide the evidence which resolves the uncertainty. (Link: http://www.sarcoma-patients.eu/index.php/download-area/clinical-trials/1...)

 

Einschlusskriterien

  • Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis
  • Sarcoma not originated from bone structure, abdominal or gynecological viscera
  • Unifocal tumor (not multifocal disease)
  • Absence of extension through the sciatic notch or across the diaphragm
  • Histologically-proven RPS (local pathologist/ imaging-guided or surgical biopsy), excluding the following histological sub-types:
    • Gastro-intestinal stromal tumor (GIST)
    • Rhabdomyosarcomas
    • PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma
    • aggressive fibromatosis
    • sarcomatoid or metastatic carcinoma
  • Tumor not previously treated (no previous surgery -excluding diagnosis biopsy-, radiotherapy or systemic therapy)
  • Tumor both operable and suitable for radiotherapy
    • This will be based on pretreatment CT scan/MRI and multidisciplinary consultation with surgeon, radiation oncologist and radiologist (anticipated macroscopically complete resection, R0/R1 resection)
    • Patients for whom surgery is expected to be R2 on the CT-scan before randomization are not eligible
    • Patients must have American Society of Anesthesiologist (ASA) score ≤ 2 (see Appendix G)
    • The criteria for non-resectability are:
      • involvement of superior mesenteric artery
      • or involvement of aorta
      • or involvement of bone
  • No metastatic disease
  • Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT (IV and PO contrast) or MRI (with IV contrast) within the 28 days prior to randomization

Ausschlusskriterien

  • ≥ 18 years old
  • WHO performance status ≤ 2 (see Appendix C)
  • Absence of history of bowel obstruction or mesenteric ischemia or severe chronic inflammatory bowel disease
  • Normal renal function:
    • Calculated creatinine clearance within normal value (calculated by Cockcroft-Gault; see Appendix E)
    • Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram (done during the baseline CTscan or differential renal isotope scan
  • Normal bone marrow and hepatic function:
    • White Blood cells ≥ 2.5 x10 9 cells/L
    • Platelets ≥ 80 x10 9 cells/L
    • Total bilirubin < 1.5 time the institutional upper limit normal of value (ULN)
    • Adequate cardiac function: less or equal to NYHA II (see Appendix D)
  • Normal 12 lead ECG (without clinically significant abnormalities)
  • Women of child bearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment
  • Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 1 month after the surgery. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
  • Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and for at least 1 month after the surgery
  • No co-existing malignancy within the last 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No prior abdominal or pelvic irradiation for other prior malignancy or other disease
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
  • Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
  • Patients will be eligible for the translational research program if they are eligible for the clinical trial and have given their written informed consent to participate in this program. If patient refuses to take part in the translational research project, patient remains eligible for the clinical trial

Aktuelles

15.09.2017: Zur Verstärkung unseres Teams suchen wir: Eine/n Sekretär/in in Teilzeit.

Mehr Infos: Stellenausschreibungen


05.09.2017:
NOA Tagung 2017
14. – 15.09.2017
MRI München
Programmflyer
Tagungsposter


30.08.2017:
Two PhD positions in Physics to assign. Read more: Stellenausschreibungen


25.07.2017:
Wir stellen ein:
Consultant (Oberarzt/Oberärztin), MTRA, Technische/n Mitarbeiter/in - Biologielaboranten/in / BTA / MTA / CTA.
Mehr Infos: Stellenausschreibungen


Dr. Kai BormUnser Assistenzarzt Herr Dr. med. Kai Borm wurde auf der DEGRO 2017 mit dem DEGRO-Dissertationspreis ausgezeichnet.
Mehr dazu: hier


Frau Univ-Prof. Dr. med. Stephanie E. Combs zum Thema: Radioonkologie als effiziente Ersttherapie bei Prostata-Krebs.
Der Artikel zum Nachlesen: ÄrzteZeitung, 66-114, 19.06.2017


TUM Radiation Oncology - Heading forward in Information Technology:
Der Artikel zum Nachlesen: ENLIGHT Juni 2017


combs.jpgFrau Univ-Prof. Dr. med. Stephanie E. Combs: Neuer Artikel im BPS Magazin über das Thema "Risiko für Sekundärmalignome nach einer Strahlentherapie der Prostata oder der Prostataloge“ erschienen.
Der Artikel zum Nachlesen: BPS Magazin 1/2017
 


Degro 2017:

DEGRO 2017 Team RadioOnkologie


DEGRO Pressemitteilung: Strahlentherapeut: Ein spannender und abwechslungsreicher Beruf – Flexibilität bei der Arbeitszeit und viele Karrieremöglichkeiten