Testing higher radiation doses for head and neck cancer with low oxygen
Tests higher radiation doses in adults with head and neck cancer and low oxygen.
Plain-language title generated from the registry record
Registry title: Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging
Key facts
- Where
- Berlin, Dresden, Freiburg im Breisgau, Heidelberg, Leipzig, Mannheim, München, and Würzburg, GermanySee the 8 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with head and neck squamous cell carcinoma who will have radiation and chemotherapy together. It tests a higher radiation dose for tumours low in oxygen.
- Age
- Older than 18 years
- Sex
- All sexes can join
- Disease stage
- Head and neck squamous cell carcinoma, stage III, IVA or IVB, that cannot be removed by surgery, or the patient cannot have or refuses surgery. HPV negative or HPV positive tumours.
- Earlier treatment
- No earlier radiotherapy in the head and neck region. Cisplatin chemotherapy must be possible with no contraindication. A dental check and treatment is needed before therapy starts.
- Biomarker or test result
- HPV negative or HPV positive tumour. The summary says HPV negative patients with low-oxygen (hypoxic) tumours after 2 weeks of radiochemotherapy are randomized.
Main reasons for not taking part
- Distant metastases (stage IVC)
- Previous radiotherapy in the head and neck region
- Pregnant or breastfeeding women
- Nasopharyngeal carcinoma
- Serious disease with life expectancy of less than one year
Read by machine on 9 November 2026.
Where in Germany
- Charité University HospitalBerlin, GermanyNo longer taking part
- Mechthild KrauseDresden, GermanyNo longer taking part
- Medical Faculty, Albert-Ludwigs-Universität Freiburg, Department of Radiation OncologyFreiburg im Breisgau, GermanyNo longer taking part
- Department of Radiation Oncology Heidelberg University Medical SchoolHeidelberg, GermanyNo longer taking part
- Universitatsklinikum LeipzigLeipzig, GermanyNo longer taking part
- Universitätsmedizin Mannheim Klinik für Strahlentherapie und RadioonkologieMannheim, GermanyNo longer taking part
- Ludwig-Maximilian-Universität, Klinikum GroßhadernMünchen, GermanyNo longer taking part
- Uniklinikum WuerzburgWürzburg, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Technische Universität Dresden
- Trial code
- NCT03865277
- Record updated
- 11 September 2023
- Original description
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.Read full original descriptionShow less
Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging: Multi-center, Randomized Phase-II-trial
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.
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: 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; Refusal of the patients to take part in the trial; Presence of distant metastases (UICC stage IVC); 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.