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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Head and Neck Neoplasms, Carcinoma, Squamous Cell

Intervention / Treatment
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* Radiation: standard dose prescription
* Radiation: FDG-PET guided gradient dose prescription


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard dose prescription<br>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<br>* standard elective dose no intermediate dose-level visual interpretation of FDG-PET-scan<br>|
| Experimental: FDG-PET guided gradient dose prescription<br>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<br>* de-escalation of elective dose intermediate dose-level standardized methods to evaluate FDG-PET-scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: recurrence in electively irradiated lymph nodes | A Kaplan-Meier estimate will be calculated | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, accelerated radiotherapy, dose reduction, dose de-escalation, elective lymph nodes, FDG-PET