Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity (UPGRADE-RT)

Radboud University Medical Center

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Squamous Cell; Head and Neck Neoplasms

Treatments: Radiation: standard dose prescription; Radiation: FDG-PET guided gradient dose prescription

Study type: Interventional

Funder types: Other

Identifiers

NCT02442375

UPGRADE-RT v3.5 dd20201201

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

standard dose prescription

Active Comparator group

Description:

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

Treatment:

Radiation: standard dose prescription

FDG-PET guided gradient dose prescription

Experimental group

Description:

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

Treatment:

Radiation: FDG-PET guided gradient dose prescription