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Uniform FDG‐PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity (UPGRADE-RT)

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ClinicalTrials.gov Identifier: NCT02442375
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
UMC Utrecht
VU University Medical Center
Maastro Clinic, The Netherlands
Radiotherapiegroep
Information provided by (Responsible Party):
Radboud University

Brief 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.

A summary of the study protocol can be found here: http://rdcu.be/qgMv


Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Carcinoma, Squamous Cell Radiation: standard dose prescription Radiation: FDG‐PET guided gradient dose prescription Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: standard dose prescription
  • FDG-PET-scan in treatment mask for radiotherapy planning
  • Accelerated radiotherapy IMRT/VMAT with SIB (34 fraction in 5.5 weeks)
Radiation: standard dose prescription
  • standard elective dose
  • no intermediate dose-level
  • visual interpretation of FDG-PET-scan

Experimental: FDG‐PET guided gradient dose prescription
  • FDG-PET-scan in treatment mask for radiotherapy planning
  • Accelerated radiotherapy IMRT/VMAT with SIB (34 fraction in 5.5 weeks)
Radiation: FDG‐PET guided gradient dose prescription
  • de-escalation of elective dose
  • intermediate dose-level
  • standardized methods to evaluate FDG-PET-scan




Primary Outcome Measures :
  1. Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Safety: recurrence in electively irradiated lymph nodes [ Time Frame: 24 months ]
    A Kaplan-Meier estimate will be calculated


Other Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour
  3. 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.
  4. Radiotherapy planned to start within 6 weeks from baseline imaging of tumour assessment
  5. No distant metastasis (M0) (TNM 7th edition 2009)
  6. WHO performance status 0‐2
  7. ≥ 18 years of age
  8. Written informed consent

Exclusion Criteria:

  1. Concomitant chemotherapy or EGFR inhibitors for this tumour.
  2. Primary tumour of the oral cavity or unknown primary tumour
  3. 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.
  4. Current participation in any other oncologic interventional clinical study for this tumor.
  5. Uncontrolled diabetes mellitus.
  6. Known or suspected HIV infection.
  7. 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)..
  8. Any condition (somatic, psychological, familial, sociological or geographical) rendering the patient unable to understand or complete questionnaires.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442375


Contacts
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Contact: Drs. S. van den Bosch +31 (0) 24 361 45 15 sven.vandenbosch@radboudumc.nl
Contact: Dr. T. Dijkema +31 (0) 24 361 45 15 tim.dijkema@radboudumc.nl

Locations
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Netherlands
VU University Medical Center Amsterdam Recruiting
Amsterdam, Netherlands
Contact: Drs. M.R. Vergeer    +31 (0) 20 44 415 71    mr.vergeer@vumc.nl   
Radiotherapiegroep, Arnhem Recruiting
Arnhem, Netherlands
Contact: Dr. B. Kreike    +31 (0) 26 37 12 412    B.Kreike@radiotherapiegroep.nl   
MAASTRO clinic, Maastricht Recruiting
Maastricht, Netherlands
Contact: Dr. F.J.P. Hoebers    +31 (0) 88 44 55 666    frank.hoebers@maastro.nl   
Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Netherlands
Contact: Prof. Dr. J.H.A.M. Kaanders    +31 (0) 24 361 45 15    j.kaanders@radboudumc.nl   
Contact: Drs. S. van den Bosch    +31 (0) 24 361 45 15    sven.vandenbosch@radboudumc.nl   
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: Prof. Dr. C.H.J. Doornaert    +31 (0) 88 75 588 00    P.A.H.Doornaert@umcutrecht.nl   
Contact: Dr. P.A.H. Terhaard    +31 (0) 88 75 588 00    c.h.j.terhaard@umcutrecht.nl   
Sponsors and Collaborators
Radboud University
UMC Utrecht
VU University Medical Center
Maastro Clinic, The Netherlands
Radiotherapiegroep
Investigators
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Study Chair: Prof. Dr. J.H.A.M. Kaanders Radboud University Nijmegen Medical Center

Additional Information:
Publications:
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02442375     History of Changes
Other Study ID Numbers: UPGRADE-RT v3.4 dd20170724
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019
Keywords provided by Radboud University:
head and neck cancer
accelerated radiotherapy
dose reduction
dose de-escalation
elective lymph nodes
FDG-PET
Additional relevant MeSH terms:
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Carcinoma
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents