TheranosticTrials.org

Clinical Trial · NCT03865277

Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging

Overview

The trial evaluates the value of radiation dose escalation based on Hypoxia detection by 18F\_misonidazole Positron Emission Tomography (18F-MISO-PET) for primary radiochemotherapy of head and neck squamous cell carcinoma. Patients negative for human papillomavirus (HPV) and with hypoxic tumours after 2 weeks of radiochemotherapy are randomized to completion of standard radiochemotherapy or radiochemotherapy with escalated radiation dose. An additional interventional arm includes a carbon ion boost. HPV positive tumours can be included in a control arm. Primary endpoint is local tumour control 2 years after radiochemotherapy.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Mechthild Krause, Prof. (STUDY_CHAIR)

Esther Troost, Prof.Dr.Dr. (CONTACT)

esther.troost@uniklinikum-dresden.de

+49 351 458 7433

Mechthild Krause, Prof. Dr. (CONTACT)

mechthild.krause@uniklinikum-dresden.de

+49 351 458 2238

ClinicalTrials.gov

NCT03865277

Drug / Compound

misonidazole

Isotope(s):
Target(s):
  • Hypoxia
Ligand Class: Small Molecules

Eligibility

Inclusion

  • HPV negative tumors or HPV positive tumors
  • Histological proven HNSCC
  • For women with childbearing potential and men in reproductive ages adequate contraception.
  • Stage III, IVA or IVB HNSCC according to UICC and AJCC guidelines
  • Ability of subject to understand character and individual consequences of the clinical trial
  • Simultaneous standard chemotherapy with cisplatin applicable (no contra-indications)
  • Tumor extension and localization suitable for radiochemotherapy with curative intent
  • Dental examination and -treatment before start of therapy
  • Tumor classified as irresectable or patient inoperable or patient refused surgery
  • WHO (ECOG) performance status 0-2

Exclusion

  • Serious disease or medical condition with life expectancy of less than one year
  • Previous radiotherapy in the head and neck region
  • Patients not able to understand the character and individual consequences of the trial
  • Patients who are not suitable for radiochemotherapy
  • Nasopharyngeal Carcinomas
  • Presence of distant metastases (UICC stage IVC)
  • Participation in competing interventional trial on cancer treatment