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

Head and Neck Neoplasms Clinical Trial

— UPGRADE-RT  

Official title:

Uniform 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442375
• Other study ID #: UPGRADE-RT v3.5 dd20201201
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: March 8, 2024

Study information

• Verified date: January 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 8, 2024
• Est. primary completion date: March 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

Radiation:
• standard dose prescription
standard elective dose no intermediate dose-level visual interpretation of FDG-PET-scan
• FDG-PET guided gradient dose prescription
de-escalation of elective dose intermediate dose-level standardized methods to evaluate FDG-PET-scan

Locations

Country	Name	City	State
Netherlands	VU University Medical Center Amsterdam	Amsterdam
Netherlands	Radiotherapiegroep, Arnhem	Arnhem
Netherlands	MAASTRO clinic, Maastricht	Maastricht
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (5)

Lead Sponsor	Collaborator
Radboud University Medical Center	Amsterdam UMC, location VUmc, Maastro Clinic, The Netherlands, Radiotherapiegroep, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van den Bosch S, Dijkema T, Kunze-Busch MC, Terhaard CH, Raaijmakers CP, Doornaert PA, Hoebers FJ, Vergeer MR, Kreike B, Wijers OB, Oyen WJ, Kaanders JH. Uniform FDG-PET guided GRAdient Dose prEscription to reduce late Radiation Toxicity (UPGRADE-RT): study protocol for a randomized clinical trial with dose reduction to the elective neck in head and neck squamous cell carcinoma. BMC Cancer. 2017 Mar 21;17(1):208. doi: 10.1186/s12885-017-3195-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute toxicity (common toxicity criteria v2.0)		up to 3 months
Other	Late toxicity: swallowing function (water swallowing test)		3, 12 and 24 months
Other	Late toxicity: salivary gland function (stimulated flow rates)		3, 12 and 24 months
Other	Late toxicity: thyroid gland function (thyroid stimulating hormone blood test)		3, 12 and 24 months
Other	Quality of life (EORTC QLQ-C30 and QLQ-H&N35 questionnaires)		3, 6, 12 and 24 months
Other	Xerostomia related quality of life (GRIX questionnaire)		3, 6, 12 and 24 months
Other	Dysphagia related quality of life (SWAL-QOL questionnaire)		3, 6, 12 and 24 months
Other	Loco-regional control	A Kaplan-Meier estimate will be calculated	24 months
Other	Overall survival	A Kaplan-Meier estimate will be calculated	24 months
Other	Disease specific survival	A Kaplan-Meier estimate will be calculated	24 months
Primary	Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients)		12 months
Secondary	Safety: recurrence in electively irradiated lymph nodes	A Kaplan-Meier estimate will be calculated	24 months

External Links

•   Study protocol