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Completed

NCT Number: NCT02442375

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VU University Medical Center Amsterdam, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Concomitant chemotherapy or EGFR inhibitors for this tumour.
  • Primary tumour of the oral cavity or unknown primary 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.
  • Current participation in any other oncologic interventional clinical study for this tumor.
  • 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.

Treatment and study plan

standard dose prescription

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

FDG-PET guided gradient dose prescription

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

Primary outcomes

  1. Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients)

    Time frame: 12 months

Secondary outcomes

  1. Safety: recurrence in electively irradiated lymph nodes

    Time frame: 24 months

    A Kaplan-Meier estimate will be calculated

Other outcomes

  1. Acute toxicity (common toxicity criteria v2.0)

    Time frame: up to 3 months

  2. Late toxicity: swallowing function (water swallowing test)

    Time frame: 3, 12 and 24 months

  3. Late toxicity: salivary gland function (stimulated flow rates)

    Time frame: 3, 12 and 24 months

  4. Late toxicity: thyroid gland function (thyroid stimulating hormone blood test)

    Time frame: 3, 12 and 24 months

  5. Quality of life (EORTC QLQ-C30 and QLQ-H&N35 questionnaires)

    Time frame: 3, 6, 12 and 24 months

  6. Xerostomia related quality of life (GRIX questionnaire)

    Time frame: 3, 6, 12 and 24 months

  7. Dysphagia related quality of life (SWAL-QOL questionnaire)

    Time frame: 3, 6, 12 and 24 months

  8. Loco-regional control

    Time frame: 24 months

    A Kaplan-Meier estimate will be calculated

  9. Overall survival

    Time frame: 24 months

    A Kaplan-Meier estimate will be calculated

  10. Disease specific survival

    Time frame: 24 months

    A Kaplan-Meier estimate will be calculated

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Maastro Clinic, The Netherlands
  • Radiotherapiegroep
  • UMC Utrecht

Registry information

Official study title

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

Acronym: UPGRADE-RT

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
May 13, 2015
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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