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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
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
VU University Medical Center Amsterdam
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Radiotherapiegroep Arnhem
Coordinator of this site? Confirm its status
ArnhemNetherlandsUnknown status
MAASTRO clinic, Maastricht
Coordinator of this site? Confirm its status
MaastrichtNetherlandsUnknown status
Radboud University Nijmegen Medical Center
Coordinator of this site? Confirm its status
NijmegenNetherlandsUnknown status
University Medical Center Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.