niform 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

Phase 3

Completed

• Conditions: head and neck cancer; squamous cell carcinoma; 10027655

• Registration Number: NL-OMON44880
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1) Newly diagnosed tumours classified as stage T2-4 N0-2 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)
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) 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.
3) Current participation in any other interventional clinical study.
4) Uncontrolled diabetes mellitus.
5) Known or suspected HIV infection.
6) 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, and basal/squamous cell carcinoma of the skin.
7) Any condition (somatic, psychological, familial, sociological or geographical) rendering the patient unable to understand or complete questionnaires.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Morbidity: dysphagia measured as the *normalcy of diet* score of the<br /><br>Performance Status Scale for Head & Neck Cancer Patients (PSS-HN) at 1 year<br /><br>after treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary endpoint: Safety: actuarial rate of recurrence in electively<br /><br>irradiated lymph nodes at 2 years after treatment.<br /><br>Other endpoints: Acute toxicity, late toxicity with focus on swallowing<br /><br>function, thyroid gland and salivary glands function, quality of life after<br /><br>treatment with focus on xerostomia and dysphagia, loco-regional control and<br /><br>survival.</p><br>