NCT02442375CompletedPhase 3
Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity
Uniform FDG-PET Guided GRAdient Dose prEscription to Reduce Late Radiation Toxicity (UPGRADE-RT): a Randomised Controlled Trial With Dose Reduction to the Elective Neck in Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
The objective of the UPGRADE-RT trial is to investigate whether de-escalation of elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation sequelae and improved quality of life after treatment whilst the recurrence rate in electively irradiated lymph nodes should not be compromised. The full study protocol can be found here: https://doi.org/10.1200/jco-24-02194
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 21 Apr 2015
- Start date
- Jun 2016
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Head and neck cancer
- NCT number
- NCT02442375
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 300
- From Jun 2016 to the primary completion date, 3 Jul 2024
- 5 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled diabetes mellitus.
- Known or suspected HIV infection.
- History of previous malignancy within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, basal/squamous cell carcinoma of the skin, and other non-invasive malignancies (e.g. in situ carcinomas)..
- Any condition (somatic, psychological, familial, sociological or geographical) rendering the patient unable to understand or complete questionnaires.
Lab values
- Concomitant chemotherapy or EGFR inhibitors for this tumour.
- Prior or current anticancer treatment to the head and neck area (e.g. radical attempted or tumour reductive surgery, neo-adjuvant or concomitant chemotherapy, EGFR inhibitors or radiotherapy), except for endoscopic glottic laser micro surgery.
Other
- Primary tumour of the oral cavity or unknown primary tumour
- Current participation in any other oncologic interventional clinical study for this tumor.
Who the study is looking for
- Newly diagnosed tumours classified as stage T2-4 N0-2 (TNM 7th edition 2009) located in the larynx, oropharynx or hypopharynx (unknown primary and oral cavity are not eligible)
- Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour
- Decision for curative intent external beam radiotherapy with elective treatment of the neck made by a multidisciplinary head-and-neck oncology team. The patient must be expected to complete the treatment.
- Radiotherapy planned to start within 6 weeks from baseline imaging of tumour assessment
- No distant metastasis (M0) (TNM 7th edition 2009)
- WHO performance status 0-2
- ≥ 18 years of age
- Written informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VU University Medical Center Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Radiotherapiegroep Arnhem Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
| MAASTRO clinic, Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Radboud University Nijmegen Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.