Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity

NCT02442375 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-11-18

No results posted yet for this study

Summary

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

Conditions

  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell

Interventions

RADIATION

FDG-PET guided gradient dose prescription

* de-escalation of elective dose * intermediate dose-level * standardized methods to evaluate FDG-PET-scan

RADIATION

standard dose prescription

* standard elective dose * no intermediate dose-level * visual interpretation of FDG-PET-scan

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER
  • Amsterdam UMC, location VUmc

    collaborator OTHER
  • Maastro Clinic, The Netherlands

    collaborator OTHER
  • Radiotherapiegroep

    collaborator OTHER
  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Prof. Dr. J.H.A.M. Kaanders · Radboud University Nijmegen Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2024-07-03
Completion
2024-07-03

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02442375 on ClinicalTrials.gov