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


  Für Patientenanfragen und
  Terminvereinbarung:

  Privatambulanz
  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
 
Tel.: + 49 89 4140 - 4304

ESCALOX

Impact of Selective Radiation Dose Escalation and Tumour Hypoxia Status on Locoregional Tumour Control After Radiochemotherapy of HNT 

The major clinical problem and predominant cause of death after radio-oncological treatment of H+N cancers are loco-regional relapses. This randomized trial tests the hypothesis that dose escalated Intensity Modulated Radiotherapy (IMRT) selectively applied to the macroscopic primary tumor and involved neck nodes - which both in 80% - are hypoxic improves loco-regional control by at least 15% at 2 years. IMRT is combined with concurrent Cis-Platin chemotherapy. Tumor volume which correlates with number of malignant cells as well as tumor hypoxia are important biological parameters which increase radio-resistance, failure of local control and tumor progression. Basing on data of experimental and clinical radiation oncology we consider hypoxia as a useful parameter for pre-therapeutic strati-fication in future randomized radio-chemotherapy trials.
In addition, hypoxia imaging by PET can be used for testing the significance of selective dose escalation on hypoxic tumor sub-volumes ("Dose Painting").
As a prerequisite for such innovative studies addressing hypoxia the translational part investigates the following key issues: correlation between the size of total tumor volume (primary, lymph nodes) and hypoxic sub-volume, the spatial shift of the hypoxic sub-volume before start of treatment and the correlation of loco-regional control and hypoxia.
Before starting the main study a pre-study to assess the occurrence of radiation induced toxicities is mandatory to be performed. In a step-wise dose-escalation in a cohort-design the safety of dose-escalation should be determined. Step one: 6 patients Step two: 14 patients. In the pre-study the 1st group (6 patients) should be treated with 2.2 Gy up to 77.0 Gy for DEVPT and DEVLK. After evaluation of the toxicity the next 14 patients should be treated by this scheme.

Inclusion Criteria:

  • Signed written informed consent
  • Age ≥ 18 ≤ 70 years
  • Independent of gender
  • Independent of race
  • ECOG 0 - 2
  • Tumor of oral cavity, oropharynx or hypopharynx
  • Histology: squamous cell carcinoma
  • Curative treatment intended
  • Tumor is classified as irresectable (see Appendix)
  • Woman of child-bearing age: negative pregnancy test in serum
  • Contraception in male and female patients and their partners if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post therapy
  • Sufficient bone marrow reserves during 7 days before study inclusion; (leukocytes ≥ 4 x 109/l, absolute no. of neutrophiles (ANC) ≥ 2 x 109/; thrombocyte count ≥ 100 x 109/l; Hemoglobin ≥ 10g/dl)
  • adequate liver function during 7 days before study inclusion (total bilirubine ≤ 2,5 x ULN (upper limit of normal), ASAT/ ALAT ≤ 2,5 x ULN, alkaline phosphatase ≤ 2,5 x ULN of the institution's normal value)
  • adequate kidney function during 7 days before study inclusion; serum creatinine ≤ 130 μmol/l; creatinine clearance ≥ 70 ml/min
  • all patients should have a dental examination before starting therapy and when necessary be treated, adaptation of a teeth protection bar
  • a percutane feeding tube should be applied before start of treatment

Exclusion Criteria:

  • Infiltration of the mandible and / or larynx
  • impaired renal and/ or liver function
  • secondary malignancy, unknown primary cancer, nasopharynx cancer or salivary gland cancers
  • Metastatic disease
  • Another cancer within 5 years of study entry
  • Serious concomitant disease or medical condition
  • Pregnancy or lactation
  • Women of child-bearing potential with unclear contraception (post menopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential)
  • previous treatment with chemotherapy, radiotherapy or surgery in head and neck (except an excisional biopsy or biopsy for histology)
  • concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
  • life expectancy of < 12 months
  • contraindications to receive Cisplatin
  • social situations that limit compliance with study requirements

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