Status:
NOT_YET_RECRUITING
Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging
Lead Sponsor:
Technische Universität Dresden
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 sq...
Detailed Description
Previous preclinical data and a prospective validated patient cohort have shown that patients with head and neck squamous cell carcinoma, whose tumours are hypoxic after 2 weeks of primary radiochmeot...
Eligibility Criteria
Inclusion
- Age: older than 18 years
- WHO (ECOG) performance status 0-2
- Histological proven HNSCC
- HPV negative tumors or HPV positive tumors
- Stage III, IVA or IVB HNSCC according to UICC and AJCC guidelines
- Tumor classified as irresectable or patient inoperable or patient refused surgery
- Tumor extension and localization suitable for radiochemotherapy with curative intent
- Simultaneous standard chemotherapy with cisplatin applicable (no contra-indications)
- Dental examination and -treatment before start of therapy
- For women with childbearing potential and men in reproductive ages adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Exclusion
- Refusal of the patients to take part in the trial
- Presence of distant metastases (UICC stage IVC)
- Previous radiotherapy in the head and neck region
- Second malignancy that is likely to require treatment during the trial intervention or follow-up period or that, in the opinion of the physician, has a considerable risk of recurrence or metastases within the follow-up period
- Serious disease or medical condition with life expectancy of less than one year
- Participation in competing interventional trial on cancer treatment
- Patients who are not suitable for radiochemotherapy
- Pregnant or lactating women
- Patients not able to understand the character and individual consequences of the trial
- Nasopharyngeal Carcinomas
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT03865277
Start Date
July 1 2024
End Date
September 30 2027
Last Update
September 11 2023
Active Locations (8)
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1
Medical Faculty, Albert-Ludwigs-Universität Freiburg, Department of Radiation Oncology
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
Department of Radiation Oncology Heidelberg University Medical School
Heidelberg, Baden-Wurttemberg, Germany, 69120
3
Universitätsmedizin Mannheim, Klinik für Strahlentherapie und Radioonkologie
Mannheim, Baden-Wurttemberg, Germany, 68167
4
Uniklinikum Wuerzburg
Würzburg, Bavaria, Germany, 97080