Clinical trial NCT02442375: Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Neoplasms
Carcinoma, Squamous Cell
Keywords: head and neck cancer
accelerated radiotherapy
dose reduction
dose de-escalation
elective lymph nodes
FDG-PET
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Amsterdam UMC, location VUmc
name: Maastro Clinic, The Netherlands
name: Radiotherapiegroep
First posted: 2015-05-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients)
timeFrame: 12 months
Secondary outcomes:
measure: Safety: recurrence in electively irradiated lymph nodes
timeFrame: 24 months
Other outcomes:
measure: Acute toxicity (common toxicity criteria v2.0)
timeFrame: up to 3 months
measure: Late toxicity: swallowing function (water swallowing test)
timeFrame: 3, 12 and 24 months
measure: Late toxicity: salivary gland function (stimulated flow rates)
timeFrame: 3, 12 and 24 months
measure: Late toxicity: thyroid gland function (thyroid stimulating hormone blood test)
timeFrame: 3, 12 and 24 months
measure: Quality of life (EORTC QLQ-C30 and QLQ-H&N35 questionnaires)
timeFrame: 3, 6, 12 and 24 months
measure: Xerostomia related quality of life (GRIX questionnaire)
timeFrame: 3, 6, 12 and 24 months
measure: Dysphagia related quality of life (SWAL-QOL questionnaire)
timeFrame: 3, 6, 12 and 24 months
measure: Loco-regional control
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Disease specific survival
timeFrame: 24 months
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center Amsterdam
city: Arnhem
country: Netherlands
facility: Radiotherapiegroep, Arnhem
city: Maastricht
country: Netherlands
facility: MAASTRO clinic, Maastricht
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Prof. Dr. J.H.A.M. Kaanders
role: STUDY_CHAIR
References:
citation: 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.