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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2024-07-03

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.

The full study protocol can be found here:

https://doi.org/10.1200/jco-24-02194

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Detailed Description

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Conditions

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Head and Neck Neoplasms Carcinoma, Squamous Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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standard dose prescription

* FDG-PET-scan in treatment mask for radiotherapy planning
* Accelerated radiotherapy IMRT/VMAT with SIB (34 fraction in 5.5 weeks)

Group Type ACTIVE_COMPARATOR

standard dose prescription

Intervention Type RADIATION

* standard elective dose
* no intermediate dose-level
* visual interpretation of FDG-PET-scan

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)

Group Type EXPERIMENTAL

FDG-PET guided gradient dose prescription

Intervention Type RADIATION

* de-escalation of elective dose
* intermediate dose-level
* standardized methods to evaluate FDG-PET-scan

Interventions

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standard dose prescription

* standard elective dose
* no intermediate dose-level
* visual interpretation of FDG-PET-scan

Intervention Type RADIATION

FDG-PET guided gradient dose prescription

* de-escalation of elective dose
* intermediate dose-level
* standardized methods to evaluate FDG-PET-scan

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No