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

Phase 3

Completed

• Conditions: Head and Neck Neoplasms; Carcinoma, Squamous Cell
• Interventions: Radiation: standard dose prescription; Radiation: FDG-PET guided gradient dose prescription

• Registration Number: NCT02442375
• Lead Sponsor: Radboud University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-13
• Study Start: 2016-06
• Status Verified: 2022-01
• Primary Completion: 2024-03-08
• Study Completion: 2024-03-08
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard dose prescription	standard dose prescription	* FDG-PET-scan in treatment mask for radiotherapy planning * Accelerated radiotherapy IMRT/VMAT with SIB (34 fraction in 5.5 weeks)
FDG-PET guided gradient dose prescription	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)

Primary Outcome Measures

Name	Time	Method
Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients)	12 months

Secondary Outcome Measures

Name	Time	Method
Safety: recurrence in electively irradiated lymph nodes	24 months	A Kaplan-Meier estimate will be calculated

Trial Locations

Locations (5)

MAASTRO clinic, Maastricht; 🇳🇱 Maastricht, Netherlands

Radiotherapiegroep, Arnhem; 🇳🇱 Arnhem, Netherlands

VU University Medical Center Amsterdam; 🇳🇱 Amsterdam, Netherlands

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands