NCT03865277Not yet recruitingPhase 2
Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging
Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging: Multi-center, Randomized Phase-II-trial
Source: ClinicalTrials.gov · Last updated 11 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- First submitted
- 26 Feb 2019
- Start date
- 1 Jul 2024
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Technische Universität Dresden
- Diseases
- Head and neck cancer
- NCT number
- NCT03865277
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 276
- From 1 Jul 2024 to the primary completion date, 30 Sept 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy in the head and neck region
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité University Hospital Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Mechthild Krause Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Medical Faculty, Albert-Ludwigs-Universität Freiburg, Department of Radiation Oncology Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Department of Radiation Oncology Heidelberg University Medical School Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universitatsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Ludwig-Maximilian-Universität, Klinikum Großhadern Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Uniklinikum Wuerzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.