NCT02442375

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
RADIATION	standard dose prescription	* standard elective dose * no intermediate dose-level * visual interpretation of FDG-PET-scan
RADIATION	FDG-PET guided gradient dose prescription	* de-escalation of elective dose * intermediate dose-level * standardized methods to evaluate FDG-PET-scan

Timeline

• Start date: 2016-06-01
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2015-05-13
• Last updated: 2025-11-18

Locations

5 sites across 1 country: Netherlands