Trial Title:
a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients
NCT ID:
NCT06248996
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
Head and neck squamous cell carcinoma
radiotherapy
HNSCC
Hyperfractionated radiotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Hyperfractionated radiotherpy
Description:
83.0 Gy in 68 fractions, 1.22 Gy per fraction, two daily fractions, five days per week to
the primary tumour volume (GTVT_83.0). To the primary tumour with an added margin
(PTVT_74.8) and to neck node metastases (PTVN_74.8) the prescribed dose will be 74.8 Gy
in 68 fractions, 1.10 Gy per fraction twice daily. To elective neck nodes (PTV 54.4) the
prescribed dose will be 54.4 Gy in 68 fractions, 0.80 Gy per fraction twice daily.
Arm group label:
HFX-RT group
Other name:
HFX-RT
Intervention type:
Radiation
Intervention name:
Control group
Description:
68.0 Gy in 34 fractions, 2.00 Gy per fraction per day, five or six days per week to
tumour volumes and 54.4 Gy in 34 fractions, 1.60 Gy per fraction to elective neck nodes.
Arm group label:
Conventionally fractioned (standard) group
Other name:
standard treatment
Summary:
There is an unmet need to personalise treatment for patients with head and neck squamous
cell carcinoma (HNSCC) and to improve treatment results for patients with advanced
disease. In this phase III study, HNSCC patients with prognostic factors indicating
increased risk of treatment failure that are aimed for curative treatment with
radiotherapy (RT) will be randomised between standard treatment (conventionally
fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final
RT dose 83.0 Gy.
In order to find better prognostic and predictive tools the study also includes
exploratory and translational analyses including evaluation of grade of hypoxia with
Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune
profiling, comparisons of global gene expression, gene aberrations and protein
expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation
and during patient follow-up. Patients with tumours with lower risk of recurrence, not
eligible for randomisation in the study, can still participate in the translational parts
of the study not investigating response to altered fractionation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient must be at least 18 years old.
2. Histologically or cytologically confirmed, previously untreated, HNSCC of the
oropharynx, hypopharynx, larynx or oral cavity without distant metastases and aimed
for treatment with radiotherapy (with or without concomitant chemotherapy) with
curative intent.
3. The primary tumour must fulfil the following high-risk criteria:
1. For p16+ oropharyngeal cancer: Radiographic measurement of threeorthogonal
diameters must render a tumour estimate of ≥30 cc.
2. For all other subsites and for p16- oropharyngeal cancer: Radiographic
measurement of three orthogonal diameters must render a tumour estimate of ≥20
cc.
4. The treatment may be followed but not preceded by surgery, either as a salvage
procedure or a neck dissection. An excision of a lymph node or tonsillectomy for
diagnostic purposes, does not exclude the patient from participation.
5. WHO/ECOG performance status 0-2
6. The patient must be able to understand the information about the treatment and give
a written informed consent to participate in the trial.
Exclusion Criteria:
1. Previous radiotherapy in the head and neck region.
2. Concomitant or previous malignancies, except uncomplicated basal cell carcinoma,
early (T1-2 N0) squamous cell carcinoma of the skin with follow-up time of at least
one year for squamous cell carcinomas, and except other cancer with a disease-free
follow-up of at least three years
3. Two or more synchronous primary HNSCC at time of diagnosis
4. Nasopharyngeal cancer
5. Sinonasal cancer
6. Co-existing disease prejudicing survival (expected survival < three years).
7. Pregnancy or lactation
8. Psychiatric or addictive disorders or other medical conditions which in the view of
the investigator might impair patient compliance
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gävle Hospital
Address:
City:
Gävle
Zip:
SE-803 24
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Ann-Sofie Fransson, MD
Phone:
+46 26 15 40 00
Email:
ann-sofie.fransson@regiongavleborg.se
Investigator:
Last name:
Ann-Sofie Fransson, MD
Email:
Principal Investigator
Facility:
Name:
Sahlgrenska University Hospital
Address:
City:
Göteborg
Zip:
SE-413 46
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Hedda Haugen, MD
Phone:
+46 31 343 60 42
Email:
hedda.haugen@oncology.gu.se
Investigator:
Last name:
Hedda Haugen, MD
Email:
Principal Investigator
Facility:
Name:
Jönköping Hospital
Address:
City:
Jönköping
Zip:
SE-553 05
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Mattias Olin, MD
Phone:
+46 10 24 25 942
Email:
mattias.olin@rjl.se
Investigator:
Last name:
Mattias Olin, MD
Email:
Principal Investigator
Facility:
Name:
Karlstad Hospital
Address:
City:
Karlstad
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Björn Kullinger, MD
Investigator:
Last name:
Björn Kullinger, MD
Email:
Principal Investigator
Facility:
Name:
Linköping University hospital
Address:
City:
Linköping
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Jan Rzepecki, MD
Investigator:
Last name:
Jan Rzepecki, MD
Email:
Principal Investigator
Facility:
Name:
Lund University Hospital
Address:
City:
Lund
Zip:
SE-221 85
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Maria Gebre-Medhin, MD
Phone:
+46 46 17 75 20
Email:
maria.gebre-medhin@skane.se
Investigator:
Last name:
Maria Gebre-Medhin, MD
Email:
Principal Investigator
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Zip:
SE-171 64
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Michael Gubanski, MD
Phone:
+46 8 517 700 00
Email:
michael.gubanski@sll.se
Investigator:
Last name:
Michael Gubanski, MD
Email:
Principal Investigator
Facility:
Name:
University Hospital
Address:
City:
Umeå
Zip:
SE-907 37
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Björn Zackrisson, MD
Phone:
+46 90 785 00 00
Email:
bjorn.zackrisson@onkologi.umu.se
Investigator:
Last name:
Björn Zackrisson, MD
Email:
Principal Investigator
Facility:
Name:
Uppsala Accademical Hospital
Address:
City:
Uppsala
Zip:
SE-753 09
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Zahra Taheri Kadkhoda, MD
Phone:
+46 18 611 00 00
Email:
zahra.taheri.kadkhoda@akademiska.se
Investigator:
Last name:
Zahra Taheri Kadkhoda, MD
Email:
Principal Investigator
Facility:
Name:
Västmanlands Hospital Västerås
Address:
City:
Västerås
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Zuzana Lovasova, MD
Investigator:
Last name:
Zuzana Lovasova, MD
Email:
Principal Investigator
Facility:
Name:
Örebro University Hospital
Address:
City:
Örebro
Zip:
SE-703 82
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Erik Lundin, MD
Phone:
+46 19 602 10 00
Email:
erik.lundin@regionorebrolan.se
Investigator:
Last name:
Erik Lundin, MD
Email:
Principal Investigator
Start date:
March 4, 2024
Completion date:
March 4, 2033
Lead sponsor:
Agency:
Lund University Hospital
Agency class:
Other
Source:
Lund University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06248996
