Carcinoma, Squamous Cell, Head and Neck Neoplasms
Conditions
Keywords
head and neck cancer, accelerated radiotherapy, dose reduction, dose de-escalation, elective lymph nodes, FDG-PET
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. The full study protocol can be found here: https://doi.org/10.1200/jco-24-02194
Interventions
RADIATIONstandard dose prescription
* standard elective dose * no intermediate dose-level * visual interpretation of FDG-PET-scan
RADIATIONFDG-PET guided gradient dose prescription
* de-escalation of elective dose * intermediate dose-level * standardized methods to evaluate FDG-PET-scan
Sponsors
UMC Utrecht
Amsterdam UMC, location VUmc
Maastro Clinic, The Netherlands
Radiotherapiegroep
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients) | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: recurrence in electively irradiated lymph nodes | 24 months | A Kaplan-Meier estimate will be calculated |
Other
| Measure | Time frame | Description |
|---|---|---|
| Late toxicity: salivary gland function (stimulated flow rates) | 3, 12 and 24 months | — |
| Late toxicity: thyroid gland function (thyroid stimulating hormone blood test) | 3, 12 and 24 months | — |
| Quality of life (EORTC QLQ-C30 and QLQ-H&N35 questionnaires) | 3, 6, 12 and 24 months | — |
| Xerostomia related quality of life (GRIX questionnaire) | 3, 6, 12 and 24 months | — |
| Acute toxicity (common toxicity criteria v2.0) | up to 3 months | — |
| Loco-regional control | 24 months | A Kaplan-Meier estimate will be calculated |
| Overall survival | 24 months | A Kaplan-Meier estimate will be calculated |
| Disease specific survival | 24 months | A Kaplan-Meier estimate will be calculated |
| Dysphagia related quality of life (SWAL-QOL questionnaire) | 3, 6, 12 and 24 months | — |
| Late toxicity: swallowing function (water swallowing test) | 3, 12 and 24 months | — |
Countries
Netherlands
Outcome results
None listed